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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK962183
Test Name CARTER-WALLACE, BRAND NAME 1-STEP PREGNANCY TEST  
Manufacturer NameArmkel, LLC
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeUrine hCG by visual color comparison tests
Effective Date07/10/1996
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K962183
Device Name BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
Applicant
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Applicant Contact Maureen Garner
Correspondent
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Correspondent Contact Maureen Garner
Regulation Number862.1155
Classification Product Code
LCX  
Date Received06/06/1996
Decision Date 07/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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