FDA 510(k) Applications for Medical Device Product Code: JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine)

FDA 510(k) Applications for Medical Device Product Code "JNB"
(Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K963040	BIO-RAD	MANUAL PHENYLALANINE TEST	10/01/1996
K960437	BIO-RAD	RADIAS PHENYLALANINE TEST	08/16/1996
K943547	ISOLAB, INC.	PHENYLALANINE TEST KIT	01/26/1996
K003584	MICROMASS, INC.	NEOLYNX SCREENING APPLICATION MANAGER	03/19/2001
K974047	NEOMETRICS, INC.	ACCUWELL PHENYLALANINE ASSAY	12/05/1997
K021541	PERKINELMER LIFE SCIENCES	NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT	10/28/2002
K984463	QUANTASE LTD.	QUANTASE PHE/GAL SCREENING ASSAY	02/16/1999
K000754	QUANTASE LTD.	QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT	06/19/2000
K961515	SHIELD DIAGNOSTICS, LTD.	QUANTASE PHENYLALANINE ASSAY	06/12/1996
K982307	WALLAC, INC.	WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000	02/02/1999