FDA product code KZR: Chromatography (Liquid, Gel), Clinical Use
KZR is the FDA product code for chromatography (liquid, gel), clinical use. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 15 510(k) submissions under KZR, from 8 different applicants. The average 510(k) review took 43 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Chromatography (Liquid, Gel), Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZR clearance
Top KZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Perkin-Elmer Corp. | 5 | 1986-03-17 |
| Varian Assoc., Inc. | 3 | 1985-05-24 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1978-07-27 |
| Waters Corporation | 1 | 1997-10-06 |
| U.S. Drug Testing, Inc. | 1 | 1993-05-06 |
3 more applicants have KZR clearances. See the full list in Caduvo.
Most recent KZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973074 | Waters Corporation | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | 1997-10-06 | 49 |
| K931227 | U.S. Drug Testing, Inc. | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | 1993-05-06 | 57 |
| K905538 | Millpore Corp. | COLUMNS LIQUID CHROMATOGRAPHY DPM | 1991-01-25 | 45 |
| K861392 | Syva Co. | SYVA SOLID PHASE COLUMNS SYSTEM II | 1986-06-13 | 60 |
| K860197 | The Perkin-Elmer Corp. | SERIES 410 LC PUMP | 1986-03-17 | 54 |
Recalls for KZR devices
openFDA lists no recalls for product code KZR.
Frequently asked questions
What is FDA product code KZR?
KZR is the FDA product code for chromatography (liquid, gel), clinical use. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is KZR?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZR?
Across 15 cleared submissions the average was 43 days from receipt to decision (median 45).
Which companies have the most KZR clearances?
The Perkin-Elmer Corp. (5); Varian Assoc., Inc. (3); E.I. Dupont DE Nemours & Co., Inc. (2); Waters Corporation (1); U.S. Drug Testing, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZR
- Run a recall and safety report across every KZR manufacturer
- Watch product code KZR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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