FDA product code KQN: Radioassay, Angiotensin Converting Enzyme
KQN is the FDA product code for radioassay, angiotensin converting enzyme. It is a Class II device, regulated under 21 CFR 862.1090 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under KQN, from 6 different applicants. The average 510(k) review took 87 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Radioassay, Angiotensin Converting Enzyme |
| Device class | Class II |
| Regulation | 21 CFR 862.1090 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQN clearance
Top KQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Laboratory Products Co., Ltd. | 2 | 1994-11-15 |
| Ventrex Laboratories, Inc. | 2 | 1982-05-03 |
| Thermo Electron Corporation | 1 | 2004-08-30 |
| Biotecx Laboratories, Inc. | 1 | 1986-03-17 |
| Sigma Diagnostics, Inc. | 1 | 1986-01-22 |
1 more applicants have KQN clearances. See the full list in Caduvo.
Most recent KQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041657 | Thermo Electron Corporation | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT | 2004-08-30 | 73 |
| K942497 | American Laboratory Products Co., Ltd. | ANGIOTENSIN CONVERTING ENZYME REA | 1994-11-15 | 182 |
| K913091 | American Laboratory Products Co., Ltd. | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | 1991-08-26 | 45 |
| K854876 | Biotecx Laboratories, Inc. | ALDOSTERONE DIRECT RIA KIT | 1986-03-17 | 101 |
| K854245 | Sigma Diagnostics, Inc. | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | 1986-01-22 | 93 |
Recalls for KQN devices
openFDA lists no recalls for product code KQN.
Frequently asked questions
What is FDA product code KQN?
KQN is the FDA product code for radioassay, angiotensin converting enzyme. It is a Class II device, regulated under 21 CFR 862.1090 and reviewed by the Clinical Chemistry panel.
What device class is KQN?
Class II, regulation 21 CFR 862.1090. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQN?
Across 8 cleared submissions the average was 87 days from receipt to decision (median 83).
Which companies have the most KQN clearances?
American Laboratory Products Co., Ltd. (2); Ventrex Laboratories, Inc. (2); Thermo Electron Corporation (1); Biotecx Laboratories, Inc. (1); Sigma Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQN
- Run a recall and safety report across every KQN manufacturer
- Watch product code KQN 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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