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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K850383
Device Name PRL QUIK RIA KIT
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 Number862.1625
Classification Product Code
CFT  
Date Received02/01/1985
Decision Date 03/01/1985
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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