NAK
5 FDA 510(k) clearances · Product code
192 daysmedian time to decision
408 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Test, Biotinidase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1118
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GSP NEONATAL BIOTINIDASE KIT (K131284) | Wallac OY | 2013-11-14 |
| NEONATAL BIOTINIDASE KIT, MODEL 3018 (K090123) | Perkinelmer, Inc. | 2010-03-05 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (K080294) | Astoria-Pacific, Inc. | 2008-11-04 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (K010844) | Astoria-Pacific, Inc. | 2001-09-21 |
| WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (DEN990008) | Wallac, Inc. | 2000-02-15 |
Track NAK automatically
Every clearance here is in the API, with alerts when new ones post.