FDA product code KZQ: Chromatography(Gas), Clinical Use
KZQ is the FDA product code for chromatography(gas), clinical use. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. FDA has cleared 12 510(k) submissions under KZQ, from 5 different applicants. The average 510(k) review took 45 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Chromatography(Gas), Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZQ clearance
Top KZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Perkin-Elmer Corp. | 5 | 1987-06-17 |
| Hewlett-Packard Co. | 3 | 1983-10-28 |
| Varian Assoc., Inc. | 2 | 1984-07-09 |
| Trace Analytical | 1 | 1982-02-15 |
| Peokin-Elmer Corp. | 1 | 1977-06-24 |
Most recent KZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872122 | The Perkin-Elmer Corp. | 8000 SERIES GAS CHROMATOGRAPHS | 1987-06-17 | 15 |
| K841891 | Varian Assoc., Inc. | VARIAN 3300 & 3400 GAS CHROMATOGRAPHS | 1984-07-09 | 63 |
| K832962 | Hewlett-Packard Co. | GAS CHROMATOGRAPH 5890A | 1983-10-28 | 59 |
| K831387 | The Perkin-Elmer Corp. | HS-100 HEADSPACE SAMPLING ACCESSORY | 1983-08-24 | 118 |
| K830147 | The Perkin-Elmer Corp. | SIGMA 300 GAS CHROMATROGRAPH | 1983-02-07 | 21 |
Recalls for KZQ devices
openFDA lists no recalls for product code KZQ.
Frequently asked questions
What is FDA product code KZQ?
KZQ is the FDA product code for chromatography(gas), clinical use. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is KZQ?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZQ?
Across 12 cleared submissions the average was 45 days from receipt to decision (median 38).
Which companies have the most KZQ clearances?
The Perkin-Elmer Corp. (5); Hewlett-Packard Co. (3); Varian Assoc., Inc. (2); Trace Analytical (1); Peokin-Elmer Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZQ
- Run a recall and safety report across every KZQ manufacturer
- Watch product code KZQ 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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