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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 K981892
Device Name QUICK & SURE ONESTEP HOME PREGNANCY TEST
Applicant
Abacus Diagnostics
6520 Platt Ave., #220
West Hills,  CA  91307
Applicant Contact PAMELA BAGARIA
Correspondent
Abacus Diagnostics
6520 Platt Ave., #220
West Hills,  CA  91307
Correspondent Contact PAMELA BAGARIA
Regulation Number862.1155
Classification Product Code
LCX  
Date Received05/29/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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