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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 a medical device manufactured by Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2020-11-09 under approval 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. It is manufactured by Mesa Biotech, Inc.. The 510(k) number is K201269.

When was Accula Strep A Test approved by the FDA?

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

What company makes Accula Strep A Test?

Accula Strep A Test is manufactured by Mesa Biotech, Inc..

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

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

Other Devices by Mesa Biotech, Inc.

K181443Accula RSV Test K171641Accula Flu A/Flu B Test

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 K183366GenePOC Strep AGenepoc, 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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