FDA 510(k) Applications for Medical Device Product Code: NAK (System,Test,Biotinidase)

FDA 510(k) Applications for Medical Device Product Code "NAK"
(System,Test,Biotinidase)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K010844	ASTORIA-PACIFIC,INC.	ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K	09/21/2001
K080294	ASTORIA-PACIFIC,INC.	ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT	11/04/2008
K090123	PERKINELMER, INC.	NEONATAL BIOTINIDASE KIT, MODEL 3018	03/05/2010
K131284	WALLAC OY	GSP NEONATAL BIOTINIDASE KIT	11/14/2013
DEN990008	WALLAC, INC.	WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000	02/15/2000