ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

Kit, Test, Pregnancy, Hcg, Over The Counter

BIOSCREEN MEDICAL INC.

The following data is part of a premarket notification filed by Bioscreen Medical Inc. with the FDA for One Step Hcg Pregnancy Urine Test Formats: Strip, Cassette And Midstream, Models Bm-1-1, Bm-1-2, Bm-1-3, Bm-2-1, Bm-2-2.

Pre-market Notification Details

Device IDK050305
510k NumberK050305
Device Name:ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant BIOSCREEN MEDICAL INC. RR I BOX 1045A Mildred,  PA  18632
ContactJimmy Liang
CorrespondentJimmy Liang
BIOSCREEN MEDICAL INC. RR I BOX 1045A Mildred,  PA  18632
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-08
Decision Date2005-05-23

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