UNIMARK HOME PREGNANCY TEST DEVICE

Kit, Test, Pregnancy, Hcg, Over The Counter

BIOTECH ATLANTIC, INC.

The following data is part of a premarket notification filed by Biotech Atlantic, Inc. with the FDA for Unimark Home Pregnancy Test Device.

Pre-market Notification Details

Device IDK032992
510k NumberK032992
Device Name:UNIMARK HOME PREGNANCY TEST DEVICE
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown,  NJ  07724
ContactFrancis L Deng
CorrespondentFrancis L Deng
BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown,  NJ  07724
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-25
Decision Date2003-11-21
Summary:summary

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