JNB · Class II · 21 CFR 862.1555

FDA Product Code JNB: Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine

Leading manufacturers include Bio-Rad, Quantase , Ltd. and Alpkem Corp..

15
Total
15
Cleared
235d
Avg days
1981
Since

FDA 510(k) Cleared Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine Devices (Product Code JNB)

15 devices
1–15 of 15
Cleared Oct 28, 2002
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
K021541
Perkinelmer Life Sciences
Chemistry · 171d
Cleared Mar 19, 2001
NEOLYNX SCREENING APPLICATION MANAGER
K003584
Micromass, Inc.
Chemistry · 119d
Cleared Jun 19, 2000
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
K000754
Quantase , Ltd.
Chemistry · 103d
Cleared Feb 16, 1999
QUANTASE PHE/GAL SCREENING ASSAY
K984463
Quantase , Ltd.
Chemistry · 62d
Cleared Feb 02, 1999
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
K982307
Wallac, Inc.
Chemistry · 216d
Cleared Dec 05, 1997
ACCUWELL PHENYLALANINE ASSAY
K974047
Neometrics, Inc.
Chemistry · 42d
Cleared Oct 01, 1996
MANUAL PHENYLALANINE TEST
K963040
Bio-Rad
Chemistry · 57d
Cleared Aug 16, 1996
RADIAS PHENYLALANINE TEST
K960437
Bio-Rad
Chemistry · 198d
Cleared Jun 12, 1996
QUANTASE PHENYLALANINE ASSAY
K961515
Shield Diagnostics, Ltd.
Chemistry · 63d
Cleared Jan 26, 1996
PHENYLALANINE TEST KIT
K943547
Isolab, Inc.
Chemistry · 554d
Cleared Feb 08, 1995
IMMUCHEM PHE-MW EA
K926106
Icn Biomedicals, Inc.
Chemistry · 797d
Cleared Oct 13, 1994
QUANTASE PHENYLALANINE ASSAY
K922547
Porton Cambridge , Ltd.
Chemistry · 864d
Cleared Oct 27, 1989
PHENYLALANINE (NINHYDRIN REACTION)
K891070
Alpkem Corp.
Chemistry · 240d
Cleared Dec 31, 1981
PHE/TYR KINETIC UV TEST SET
K813449
P-L Biochemicals, Inc.
Chemistry · 21d
Cleared Dec 03, 1981
PHENYLALANINE UV KINETIC TEST KIT
K813171
Biochemicals, Inc.
Chemistry · 17d

About Product Code JNB - Regulatory Context