ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.

Enzyme Immunoassay, Amphetamine

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Amp 300, Biosign Amp 300, Status Ds Amp 300, Syva Rapid Test D.a.u..

Pre-market Notification Details

Device IDK001225
510k NumberK001225
Device Name:ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
ClassificationEnzyme Immunoassay, Amphetamine
Applicant PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-17
Decision Date2000-05-17

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