Atlas FDA

JNB

15 FDA 510(k) clearances · Product code

119 daysmedian time to decision
797 days90th percentile
15clearances measured

FDA profile

Official device name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1555
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (K021541)Perkinelmer Life Sciences2002-10-28
NEOLYNX SCREENING APPLICATION MANAGER (K003584)Micromass, Inc.2001-03-19
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (K000754)Quantase , Ltd.2000-06-19
QUANTASE PHE/GAL SCREENING ASSAY (K984463)Quantase , Ltd.1999-02-16
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (K982307)Wallac, Inc.1999-02-02
ACCUWELL PHENYLALANINE ASSAY (K974047)Neometrics, Inc.1997-12-05
MANUAL PHENYLALANINE TEST (K963040)Bio-Rad1996-10-01
RADIAS PHENYLALANINE TEST (K960437)Bio-Rad1996-08-16
QUANTASE PHENYLALANINE ASSAY (K961515)Shield Diagnostics, Ltd.1996-06-12
PHENYLALANINE TEST KIT (K943547)Isolab, Inc.1996-01-26
IMMUCHEM PHE-MW EA (K926106)Icn Biomedicals, Inc.1995-02-08
QUANTASE PHENYLALANINE ASSAY (K922547)Porton Cambridge , Ltd.1994-10-13
PHENYLALANINE (NINHYDRIN REACTION) (K891070)Alpkem Corp.1989-10-27
PHE/TYR KINETIC UV TEST SET (K813449)P-L Biochemicals, Inc.1981-12-31
PHENYLALANINE UV KINETIC TEST KIT (K813171)Biochemicals, Inc.1981-12-03

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Every clearance here is in the API, with alerts when new ones post.