GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA

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 Gen-probe Rapid Diagnostic System For Mycobacteria.

Pre-market Notification Details

Device IDK864597
510k NumberK864597
Device Name:GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
ClassificationDna-reagents, Mycobacterium Spp.
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactDaniel L Kacian,phd
CorrespondentDaniel L Kacian,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 Received1986-11-24
Decision Date1987-04-20

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