GenePOC Strep A

Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

GenePOC Inc.

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

Pre-market Notification Details

Device IDK183366
510k NumberK183366
Device Name:GenePOC Strep A
ClassificationGroups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Applicant GenePOC Inc. 360 Rue Franquet Quebec,  CA G1p 4n3
ContactDany Leblanc
CorrespondentDany Leblanc
GenePOC Inc. 360 Rue Franquet Quebec,  CA G1p 4n3
Product CodePGX  
CFR Regulation Number866.2680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-04
Decision Date2019-03-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628055344087 K183366 000
00628055344179 K183366 000

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