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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 K862614
Device Name RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX
Applicant
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact ADAMS, PHD
Correspondent
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact ADAMS, PHD
Regulation Number866.3370
Classification Product Code
LQF  
Date Received07/09/1986
Decision Date 11/10/1986
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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