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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K040866
Device Name FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
Applicant
Armkel, LLC
469 N. Harrison St.
Princeton,  NJ  08543
Applicant Contact STEPHEN C KOLAKOWSKY
Correspondent
Armkel, LLC
469 N. Harrison St.
Princeton,  NJ  08543
Correspondent Contact STEPHEN C KOLAKOWSKY
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/02/2004
Decision Date 10/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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