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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 K860782
Device Name GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM
Applicant
GEN-PROBE, INC.
9620 chesapeake dr.
san diego,  CA  92123
Applicant Contact thomas h adams
Correspondent
GEN-PROBE, INC.
9620 chesapeake dr.
san diego,  CA  92123
Correspondent Contact thomas h adams
Regulation Number866.3370
Classification Product Code
LQF  
Date Received03/03/1986
Decision Date 07/02/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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