ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX 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 Avium Complex Culture.

Pre-market Notification Details

Device IDK921435
510k NumberK921435
Device Name:ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
ClassificationDna-reagents, Mycobacterium Spp.
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactRuben Chairez
CorrespondentRuben Chairez
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 Received1992-03-25
Decision Date1992-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506138 K921435 000

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