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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K924461
Device Name STREP A NEGATIVE CONTROL
Applicant
Pacific Biotech, Inc.
9050 Camino Santa Fe
San Diego,  CA  92121
Applicant Contact CONNIE KIRBY
Correspondent
Pacific Biotech, Inc.
9050 Camino Santa Fe
San Diego,  CA  92121
Correspondent Contact CONNIE KIRBY
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/02/1992
Decision Date 12/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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