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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K895390
Device Name CARDS O.S. (TM) HCG-URINE
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
JHI  
Date Received08/30/1989
Decision Date 11/13/1989
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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