ACON ONE STEP PREGNANCY TEST STRIP (URINE)

Visual, Pregnancy Hcg, Prescription Use

ACON LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK993203
510k NumberK993203
Device Name:ACON ONE STEP PREGNANCY TEST STRIP (URINE)
ClassificationVisual, Pregnancy Hcg, Prescription Use
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 CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-24
Decision Date1999-12-01
Summary:summary

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