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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 K904463
Device Name ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
Applicant
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Contact connie kirby
Regulation Number866.3370
Classification Product Code
LQF  
Date Received10/01/1990
Decision Date 11/13/1990
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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