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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 K890089
Device Name RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE
Applicant
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Applicant Contact BRUNI, PHD
Correspondent
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Correspondent Contact BRUNI, PHD
Regulation Number866.3370
Classification Product Code
LQF  
Date Received01/10/1989
Decision Date 03/13/1989
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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