BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

System, Test, Human Chorionic Gonadotropin

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biostrip(r) Hcg-one Step Pregnancy Test.

Pre-market Notification Details

Device IDK950307
510k NumberK950307
Device Name:BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
ClassificationSystem, Test, Human Chorionic Gonadotropin
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 CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-25
Decision Date1995-03-01

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