NAK · Class II · 21 CFR 862.1118

FDA Product Code NAK: System, Test, Biotinidase

Leading manufacturers include Astoria-Pacific, Inc., Wallac, Inc. and Perkinelmer, Inc..

5
Total
4
Cleared
223d
Avg days
2000
Since

FDA 510(k) Cleared System, Test, Biotinidase Devices (Product Code NAK)

5 devices
1–5 of 5
Cleared Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
K131284
Wallac OY
Chemistry · 192d
Cleared Mar 05, 2010
NEONATAL BIOTINIDASE KIT, MODEL 3018
K090123
Perkinelmer, Inc.
Chemistry · 408d
Cleared Nov 04, 2008
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
K080294
Astoria-Pacific, Inc.
Chemistry · 274d
Cleared Sep 21, 2001
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
K010844
Astoria-Pacific, Inc.
Chemistry · 184d
Not Cleared Feb 15, 2000
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000
DEN990008
Wallac, Inc.
Chemistry · 57d

About Product Code NAK - Regulatory Context