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FDA 510(k)

Solana Strep Complete Assay

K-Number: K162274 · 2016-10-25

ApplicantQuidel Corporation
Decision Date2016-10-25
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Solana Strep Complete Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-10-25 under 510(k) 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. The listed applicant is Quidel Corporation. The 510(k) number is K162274.

When did Solana Strep Complete Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for Solana Strep Complete Assay?

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

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

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

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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.K183366GenePOC 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 Corporation

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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