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FDA 510(k)

Sofia RSV FIA on Sofia 2 analyzer

K-Number: K162911 · 2017-02-22

ApplicantQuidel Corporation
Decision Date2017-02-22
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia RSV FIA on Sofia 2 analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K162911. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia RSV FIA on Sofia 2 analyzer?

Sofia RSV FIA on Sofia 2 analyzer is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Quidel Corporation. The 510(k) number is K162911.

When did Sofia RSV FIA on Sofia 2 analyzer receive FDA 510(k) clearance?

Sofia RSV FIA on Sofia 2 analyzer received FDA 510(k) clearance on 2017-02-22, under 510(k) number K162911.

Who is the listed applicant for Sofia RSV FIA on Sofia 2 analyzer?

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 Sofia RSV FIA on Sofia 2 analyzer?

The FDA product code for Sofia RSV FIA on Sofia 2 analyzer is GQG.

Other records listing Quidel Corporation 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.

K231795QuickVue COVID-19 TestK232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentK233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetK230349Lyra RSV+hMPV AssayK230236Lyra Influenza A+B AssayK211342Sofia 2 Campylobacter FIA

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Related Devices (Code: GQG)

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.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech 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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