BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES

Kit, Test, Pregnancy, Hcg, Over The Counter

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Brand Name 1-step Pregnancy Test-may Be Marketed Under First Response, Answer, Or Other Brand Names.

Pre-market Notification Details

Device IDK962183
510k NumberK962183
Device Name:BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury,  NJ  08512 -0181
ContactMaureen Garner
CorrespondentMaureen Garner
ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury,  NJ  08512 -0181
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-06
Decision Date1996-07-10
Summary:summary

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