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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K884007
Device Name CARDS(TM) MONO
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 Number866.5640
Classification Product Code
KTN  
Date Received09/21/1988
Decision Date 11/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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