ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM 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 Kansasii Cult Confirm Test.

Pre-market Notification Details

Device IDK904463
510k NumberK904463
Device Name:ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
ClassificationDna-reagents, Mycobacterium Spp.
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactConnie Kirby
CorrespondentConnie Kirby
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 Received1990-10-01
Decision Date1990-11-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506152 K904463 000

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