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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
Original Applicant
GEN-PROBE, INC.
9620 chesapeake dr.
san diego,  CA  92123
Original Contact adams, phd
Regulation Number866.3370
Classification Product Code
LQF  
Date Received07/09/1986
Decision Date 11/10/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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