FDA product code NAK: System, Test, Biotinidase
NAK is the FDA product code for system, test, biotinidase. It is a Class II device, regulated under 21 CFR 862.1118 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under NAK, from 3 different applicants. The average 510(k) review took 264 days (median 233). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Biotinidase |
| Device class | Class II |
| Regulation | 21 CFR 862.1118 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NAK clearance
Top NAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Astoria-Pacific, Inc. | 2 | 2008-11-04 |
| Wallac OY | 1 | 2013-11-14 |
| Perkinelmer, Inc. | 1 | 2010-03-05 |
Most recent NAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131284 | Wallac OY | GSP NEONATAL BIOTINIDASE KIT | 2013-11-14 | 192 |
| K090123 | Perkinelmer, Inc. | NEONATAL BIOTINIDASE KIT, MODEL 3018 | 2010-03-05 | 408 |
| K080294 | Astoria-Pacific, Inc. | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | 2008-11-04 | 274 |
| K010844 | Astoria-Pacific, Inc. | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | 2001-09-21 | 184 |
Recalls for NAK devices
openFDA lists no recalls for product code NAK.
Frequently asked questions
What is FDA product code NAK?
NAK is the FDA product code for system, test, biotinidase. It is a Class II device, regulated under 21 CFR 862.1118 and reviewed by the Clinical Chemistry panel.
What device class is NAK?
Class II, regulation 21 CFR 862.1118. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAK?
Across 4 cleared submissions the average was 264 days from receipt to decision (median 233).
Which companies have the most NAK clearances?
Astoria-Pacific, Inc. (2); Wallac OY (1); Perkinelmer, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NAK
- Run a recall and safety report across every NAK manufacturer
- Watch product code NAK 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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