ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST

Dna-reagents, Mycobacterium Spp.

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Mycobacterium Tuberculosis Complex Test.

Pre-market Notification Details

Device IDK896493
510k NumberK896493
Device Name:ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
ClassificationDna-reagents, Mycobacterium Spp.
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactBruni, Phd
CorrespondentBruni, Phd
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeLQF  
CFR Regulation Number866.3370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-13
Decision Date1990-04-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506169 K896493 000

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