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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 K864597
Device Name GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
Applicant
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Applicant Contact daniel l kacian,phd
Correspondent
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Correspondent Contact daniel l kacian,phd
Regulation Number866.3370
Classification Product Code
LQF  
Date Received11/24/1986
Decision Date 04/20/1987
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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