ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP

Enzyme Immunoassay, Amphetamine

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Amp, Doa-amp, Accusign(tm) Amp-doa-amp, Biosign(tm) Amp, Doa-amp.

Pre-market Notification Details

Device IDK945610
510k NumberK945610
Device Name:ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
ClassificationEnzyme Immunoassay, Amphetamine
Applicant PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton,  NJ  08543
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton,  NJ  08543
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-15
Decision Date1995-04-13

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