ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE

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 Intracellulare Culture.

Pre-market Notification Details

Device IDK897077
510k NumberK897077
Device Name:ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
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 Received1989-12-22
Decision Date1990-08-23

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