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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 K874823
Device Name FIRST RESPONSE 5 MINUTE PREGNANCY TEST
Applicant
Tambrands, Inc.
Bridge & Springfield St.S
Palmer,  MA  01069
Applicant Contact STAAB, PHD
Correspondent
Tambrands, Inc.
Bridge & Springfield St.S
Palmer,  MA  01069
Correspondent Contact STAAB, PHD
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/24/1987
Decision Date 04/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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