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FDA 510(k)

SOFIA(R) RSV FIA

K-Number: K130398 · 2013-08-13

ApplicantQuidel Corp.
Decision Date2013-08-13
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SOFIA(R) RSV FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K130398. 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(R) RSV FIA?

SOFIA(R) RSV FIA is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Quidel Corp.. The 510(k) number is K130398.

When did SOFIA(R) RSV FIA receive FDA 510(k) clearance?

SOFIA(R) RSV FIA received FDA 510(k) clearance on 2013-08-13, under 510(k) number K130398.

Who is the listed applicant for SOFIA(R) RSV FIA?

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

What is the FDA product code for SOFIA(R) RSV FIA?

The FDA product code for SOFIA(R) RSV FIA is GQG.

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Other records listing Quidel Corp. 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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+BK122189QUIDEL MOLECULAR RSV + HMPV ASSAY

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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 CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK121633BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson and Company

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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