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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 K863341
Device Name CARDS(TM) - EARLY PREGNANCY TEST
Applicant
Pacific Biotech, Inc.
9050 Camino Santa Fe
San Diego,  CA  92121
Applicant Contact SHU-CHING CHENG
Correspondent
Pacific Biotech, Inc.
9050 Camino Santa Fe
San Diego,  CA  92121
Correspondent Contact SHU-CHING CHENG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/28/1986
Decision Date 01/14/1987
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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