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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 the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2019-03-06 under 510(k) 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. The listed applicant is Genepoc, Inc.. The 510(k) number is K183366.

When did GenePOC Strep A receive FDA 510(k) clearance?

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

Who is the listed applicant for GenePOC Strep A?

The FDA 510(k) record lists Genepoc, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenePOC Strep A?

The FDA product code for GenePOC Strep A is PGX.

Other records listing Genepoc, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190275GenePOC CarbaK172569GenePOC CDiffK170558revogeneK170557GenePOC GBS LB

Related Devices (Code: PGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLCK201269Accula Strep A TestMesa Biotech, Inc.K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.K173398Xpert Xpress Strep ACepheidK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex CorporationK172126Xpert Xpress Strep ACepheid

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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