PURE-AID PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

BIO FOCUS CO., LT.

The following data is part of a premarket notification filed by Bio Focus Co., Lt. with the FDA for Pure-aid Pregnancy Test.

Pre-market Notification Details

Device IDK053452
510k NumberK053452
Device Name:PURE-AID PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant BIO FOCUS CO., LT. 251E. REDONDO BEACH BLVD. Gardena,  CA  90248
ContactLauren Hong
CorrespondentLauren Hong
BIO FOCUS CO., LT. 251E. REDONDO BEACH BLVD. Gardena,  CA  90248
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-12
Decision Date2006-05-25

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