ACON ONE STEP HOME PREGNANCY TEST STRIP

Kit, Test, Pregnancy, Hcg, Over The Counter

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon One Step Home Pregnancy Test Strip.

Pre-market Notification Details

Device IDK993483
510k NumberK993483
Device Name:ACON ONE STEP HOME PREGNANCY TEST STRIP
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego,  CA  92121
ContactNora C.r. York
CorrespondentNora C.r. York
ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego,  CA  92121
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-14
Decision Date2000-01-20
Summary:summary

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