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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Mycobacterium Spp.
510(k) Number K896493
Device Name ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
Applicant
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Applicant Contact BRUNI, PHD
Correspondent
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Correspondent Contact BRUNI, PHD
Regulation Number866.3370
Classification Product Code
LQF  
Date Received11/13/1989
Decision Date 04/11/1990
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
Recalls CDRH Recalls
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