Medical device manufacturer
Technicon Instruments Corp.
Technicon Instruments Corp. holds 157 FDA 510(k) clearances across 87 product codes. Median elapsed review time is 39 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 157
- Product codes
- 87
- Median review
- 39 days
- Recall records
- 0
How does FDA spell Technicon Instruments Corp.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Technicon Instruments Corp. file in?
87 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 12 | 35 days | |
| GKL | Counter, Cell, Automated (Particle Counter) | 8 | 30 days | |
| GKZ | Counter, Differential Cell | 6 | 35 days | |
| JGJ | Photometric Method, Magnesium | 6 | 63 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 35 days | |
| JGS | Electrode, Ion Specific, Sodium | 4 | 48 days | |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 4 | 35 days | |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 3 | 85 days | |
| CIC | Cresolphthalein Complexone, Calcium | 3 | 39 days | |
| CIX | Bromcresol Green Dye-Binding, Albumin | 3 | 28 days | |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 3 | 28 days | |
| JPK | Mixture, Hematology Quality Control | 3 | 59 days | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 3 | 33 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 26 days | |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 2 | 98 days | |
| CFR | Hexokinase, Glucose | 2 | 17 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 35 days | |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 27 days | |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 30 days | |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 14 days | |
| DCF | Albumin, Antigen, Antiserum, Control | 2 | 15 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 28 days | |
| DEW | Igg, Antigen, Antiserum, Control | 2 | 57 days | |
| JIY | Photometric Method, Iron (Non-Heme) | 2 | 25 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 46 days |
Showing the 25 they file in most, of 87.
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 Technicon Instruments Corp. 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 Technicon Instruments Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | CIX | 28 | |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | LBS | 49 | |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | CIT | 74 | |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | KLI | 104 | |
| K912413 | CHEM-LINK DATA BASE MANAGER | JJQ | 31 | |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | DIS | 38 | |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | DKZ | 38 | |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | KHS | 65 | |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | JGJ | 36 | |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | JJC | 113 |
Source: openFDA device/510k · retrieved
Watch what Technicon Instruments Corp. files next
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