FDA Product Code
FDA Product Code NAK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1118
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Wallac OY | 2013-11-14 | Traditional | PDF ↗ |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2008-11-04 | Traditional | PDF ↗ |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Astoria-Pacific, Inc. | 2001-09-21 | Traditional | PDF ↗ |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Wallac, Inc. | 2000-02-15 | Post-NSE | — |
Product code NAK · Class II · Clinical Chemistry. Data: openFDA.