ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR

Enzyme Immunoassay, Barbiturate

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Bar, Biosign Bar, Status Bar.

Pre-market Notification Details

Device IDK991018
510k NumberK991018
Device Name:ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
ClassificationEnzyme Immunoassay, Barbiturate
Applicant PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction,  NJ  08852 -1905
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction,  NJ  08852 -1905
Product CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-26
Decision Date1999-04-15

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