ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE 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 Gordonae Culture Test.

Pre-market Notification Details

Device IDK896492
510k NumberK896492
Device Name:ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE 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 Date1990-04-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506145 K896492 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.