ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION

Dna-reagents, Campylobacter Spp.

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Campylobacter Culture Confirmation.

Pre-market Notification Details

Device IDK894712
510k NumberK894712
Device Name:ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
ClassificationDna-reagents, Campylobacter Spp.
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactJohn F Bruni,phd
CorrespondentJohn F Bruni,phd
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeLQO  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-26
Decision Date1989-11-14

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