RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX

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 Rapid Identi. Test For Mycobacterium Tb Complex.

Pre-market Notification Details

Device IDK862614
510k NumberK862614
Device Name:RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX
ClassificationDna-reagents, Mycobacterium Spp.
Applicant GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego,  CA  92123
ContactAdams, Phd
CorrespondentAdams, Phd
GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego,  CA  92123
Product CodeLQF  
CFR Regulation Number866.3370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-09
Decision Date1986-11-10

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