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FDA 510(k)

GenePOC Strep A

K-Number: K183366 · 2019-03-06

ApplicantGenepoc, Inc.
Decision Date2019-03-06
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GenePOC Strep A is a medical device manufactured by Genepoc, Inc.. It received FDA 510(k) clearance on 2019-03-06 under approval number K183366. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GenePOC Strep A?

GenePOC Strep A is a medical device that received FDA 510(k) clearance on 2019-03-06. It is manufactured by Genepoc, Inc.. The 510(k) number is K183366.

When was GenePOC Strep A approved by the FDA?

GenePOC Strep A received FDA 510(k) clearance on 2019-03-06, under approval number K183366.

What company makes GenePOC Strep A?

GenePOC Strep A is manufactured by Genepoc, Inc..

What is the FDA product code for GenePOC Strep A?

The FDA product code for GenePOC Strep A is PGX.

Other Devices by Genepoc, Inc.

K172569GenePOC CDiff K170558revogene K170557GenePOC GBS LB K190275GenePOC Carba

Related Devices (Code: PGX)

K162274Solana Strep Complete AssayQuidel Corporation K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation K172126Xpert Xpress Strep ACepheid K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. K173398Xpert Xpress Strep ACepheid K201269Accula Strep A TestMesa Biotech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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