GenePOC CDiff

C. Difficile Toxin Gene Amplification Assay

GenePOC Inc.

The following data is part of a premarket notification filed by Genepoc Inc. with the FDA for Genepoc Cdiff.

Pre-market Notification Details

Device IDK172569
510k NumberK172569
Device Name:GenePOC CDiff
ClassificationC. Difficile Toxin Gene Amplification Assay
Applicant GenePOC Inc. 360 Rue Franquet Quebec,  CA G1p 4n3
ContactGuy Sevigny
CorrespondentGuy Sevigny
GenePOC Inc. 360 Rue Franquet Quebec,  CA G1p 4n3
Product CodeOZN  
CFR Regulation Number866.3130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-25
Decision Date2017-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628055344025 K172569 000
00628055344124 K172569 000
00840733102349 K172569 000

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