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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 K895103
Device Name ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
Applicant
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Applicant Contact JOHN BRUNI
Correspondent
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Correspondent Contact JOHN BRUNI
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received08/15/1989
Decision Date 11/29/1989
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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