NAKClass II
System, Test, Biotinidase
Clinical Chemistry · 21 CFR 862.1118
MDR events1All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances5All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Wallac OYNov 14, 2013
K131284 · GSP NEONATAL BIOTINIDASE KIT
- Perkinelmer, Inc.Mar 5, 2010
K090123 · NEONATAL BIOTINIDASE KIT, MODEL 3018
- Astoria-Pacific, Inc.Nov 4, 2008
K080294 · ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- Astoria-Pacific, Inc.Sep 21, 2001
K010844 · ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- Wallac, Inc.Feb 15, 2000
DEN990008 · WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000