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FDA 510(k)

Accula Strep A Test

K-Number: K201269 · 2020-11-09

ApplicantMesa Biotech, Inc.
Decision Date2020-11-09
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Accula Strep A Test is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K201269. 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 Accula Strep A Test?

Accula Strep A Test is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K201269.

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

Accula Strep A Test received FDA 510(k) clearance on 2020-11-09, under 510(k) number K201269.

Who is the listed applicant for Accula Strep A Test?

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

What is the FDA product code for Accula Strep A Test?

The FDA product code for Accula Strep A Test is PGX.

Other records listing Mesa Biotech, 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.

K181443Accula RSV TestK171641Accula Flu A/Flu B Test

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, LLCK183366GenePOC Strep AGenepoc, 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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