Medical device manufacturer
Harleco
Harleco holds 116 FDA 510(k) clearances across 40 product codes. Median elapsed review time is 25 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 116
- Product codes
- 40
- Median review
- 25 days
- Recall records
- 0
How does FDA spell Harleco?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Harleco file in?
40 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 8 | 25 days | |
| CEK | Biuret (Colorimetric), Total Protein | 6 | 14 days | |
| CFR | Hexokinase, Glucose | 6 | 20 days | |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 6 | 21 days | |
| CIG | Diazo Colorimetry, Bilirubin | 6 | 18 days | |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 5 | 20 days | |
| CIX | Bromcresol Green Dye-Binding, Albumin | 5 | 20 days | |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 5 | 26 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 | 19 days | |
| CIJ | Saccharogenic, Amylase | 4 | 42 days | |
| CJY | Azo Dye, Calcium | 4 | 18 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 18 days | |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 4 | 24 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 | 35 days | |
| CGA | Glucose Oxidase, Glucose | 3 | 26 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 19 days | |
| JFJ | Catalytic Methods, Amylase | 3 | 28 days | |
| JHW | U.V. Method, Cpk Isoenzymes | 3 | 21 days | |
| LFR | Glucose Dehydrogenase, Glucose | 3 | 24 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 13 days | |
| GIF | Diluent, Blood Cell | 2 | 22 days | |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 2 | 26 days | |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 2 | 48 days | |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 2 | 13 days | |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 23 days |
Showing the 25 they file in most, of 40.
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 Harleco had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Harleco cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | JQB | 15 | |
| K813427 | ULTRACHEM GLUC-DH | LFR | 24 | |
| K813044 | ULTRACHEM ALB, ITEM #64970 | CIX | 13 | |
| K813043 | ULTRACHEM CREA ITEM #64972 | CGX | 13 | |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | LFR | 13 | |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | JQB | 13 | |
| K813040 | ULTRACHEM CA, ITEM #64975 | CJY | 13 | |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | CHH | 13 | |
| K813038 | ULTRACHEM TP, ITEM #64974 | CEK | 13 | |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | CIJ | 21 |
Source: openFDA device/510k · retrieved
Watch what Harleco files next
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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.