ACON MIDSTREAM PREGNANCY TEST

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 Midstream Pregnancy Test.

Pre-market Notification Details

Device IDK983090
510k NumberK983090
Device Name:ACON MIDSTREAM PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant ACON LABORATORIES, INC. 3140-B TILGHMAN ST. SUITE 215 Allentown,  PA  18104
ContactPatricia E Bonness
CorrespondentPatricia E Bonness
ACON LABORATORIES, INC. 3140-B TILGHMAN ST. SUITE 215 Allentown,  PA  18104
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-03
Decision Date1998-11-18
Summary:summary

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