Medical device manufacturer
Helena Laboratories, Corp.
Helena Laboratories, Corp. holds 282 FDA 510(k) clearances across 83 product codes. Median elapsed review time is 56 days. openFDA lists 16 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 282
- Product codes
- 83
- Median review
- 56 days
- Recall records
- 16
How does FDA spell Helena Laboratories, Corp.?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| HELENA LABORATORIES, CORP. | device/registrationlisting | normalised |
| Helena Laboratories | device/510k | normalised |
| Helena Laboratories, Corp. | device/510k | normalised |
| Helena Laboratories, Corp. | device/recall | normalised |
| Helena Laboratories, Corp. | device/enforcement | normalised |
| Helena Laboratories, Inc. | device/recall | normalised |
| Helena Laboratories, Inc. | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Helena Laboratories, Corp. file in?
83 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 19 | 75 days | |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 17 | 38 days | |
| CEF | Electrophoretic, Protein Fractionation | 15 | 82 days | |
| JHO | Electrophoretic Separation, Lipoproteins | 15 | 54 days | |
| KHE | Reagent, Occult Blood | 12 | 81 days | |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 11 | 45 days | |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 11 | 29 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 11 | 41 days | |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 8 | 20 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 8 | 27 days | |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 7 | 42 days | |
| GGN | Plasma, Coagulation Control | 7 | 142 days | |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 6 | 80 days | |
| GHR | Reagent, Platelet Aggregation | 6 | 90 days | |
| GJS | Test, Time, Prothrombin | 6 | 75 days | |
| JPD | Hemoglobin A2 Quantitation | 6 | 40 days | |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 5 | 69 days | |
| GKP | Instrument, Coagulation, Automated | 5 | 81 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 49 days | |
| JJT | Enzyme Controls (Assayed And Unassayed) | 4 | 22 days | |
| JOZ | System, Automated Platelet Aggregation | 4 | 44 days | |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 4 | 48 days | |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 3 | 47 days | |
| DEW | Igg, Antigen, Antiserum, Control | 3 | 16 days | |
| GGW | Test, Time, Partial Thromboplastin | 3 | 58 days |
Showing the 25 they file in most, of 83.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Helena Laboratories, Corp. had a recall?
openFDA lists 16 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1975-2023Class IIOpen, ClassifiedLXG
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Z-1244-2022Class IIOpen, ClassifiedCFF
Due to microbial growth causing interference with interpretation.
Z-1108-2021Class IITerminatedGFO
Intermittent potential for shorter than expected clot times.
Z-0635-2021Class IIOpen, ClassifiedJPA
Due to complaints received associated with cracked/split test tube caps.
Z-1949-2019Class IIOpen, ClassifiedKHE
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Showing the 5 most recently initiated of 16.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Helena Laboratories, Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K213396 | SPIFE A1AT kit | OBZ | 360 | |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | GKA | 915 | |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | JJY | 138 | |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | GGC | 336 | |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | GHR | 225 | |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | CFF | 80 | |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | JPA | 27 | |
| K050053 | HEMORAM/AGGRAM ANALYZER | JPA | 182 | |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | CFF | 64 | |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | JOZ | 98 |
Source: openFDA device/510k · retrieved
Where is Helena Laboratories, Corp. registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Helena Laboratories, Corp. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.