BIOSIGN HCG I - ONE STEP PREGNANCY TEST

Visual, Pregnancy Hcg, Prescription Use

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Hcg I - One Step Pregnancy Test.

Pre-market Notification Details

Device IDK981443
510k NumberK981443
Device Name:BIOSIGN HCG I - ONE STEP PREGNANCY TEST
ClassificationVisual, Pregnancy Hcg, Prescription Use
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 CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-22
Decision Date1998-06-25

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