Panels › Clinical Chemistry › Product code NAK · Class 2
System, Test, Biotinidase
Regulation 862.1118
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NAK
| Company | 510(k)s | Recalls |
|---|---|---|
| Astoria-Pacific, Inc. | 2 | 0 |
| Wallac OY | 2 | 0 |
| Perkinelmer, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2013 | K131284 | GSP NEONATAL BIOTINIDASE KIT Wallac OY | NAK |
| Mar 5, 2010 | K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 Perkinelmer, Inc. | NAK |
| Nov 4, 2008 | K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | NAK |
| Sep 21, 2001 | K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K Astoria-Pacific, Inc. | NAK |
| Feb 15, 2000 | DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 Wallac, Inc. | NAK |
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