FDA 510(k)

Solana Strep Complete Assay

K-Number: K162274 · 2016-10-25

Decision Date2016-10-25

Product CodePGX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Solana Strep Complete Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2016-10-25 under approval number K162274. 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 Solana Strep Complete Assay?

Solana Strep Complete Assay is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Quidel Corporation. The 510(k) number is K162274.

When was Solana Strep Complete Assay approved by the FDA?

Solana Strep Complete Assay received FDA 510(k) clearance on 2016-10-25, under approval number K162274.

What company makes Solana Strep Complete Assay?

Solana Strep Complete Assay is manufactured by Quidel Corporation.

What is the FDA product code for Solana Strep Complete Assay?

The FDA product code for Solana Strep Complete Assay is PGX.

Other Devices by Quidel Corporation

K162451Solana HSV 1+2/VZV Assay K161814Solana Influenza A+B Assay K161182Solana Trichomonas Assay K153012Sofia Influenza A+B FIA K171976Sofia Strep A+ FIA, Sofia 2 Analyzer K173250Solana GBS Assay

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Related Devices (Code: PGX)

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. K201269Accula Strep A TestMesa Biotech, Inc.

Official Source

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