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FDA 510(k)

Sofia Influenza A+B FIA on Sofia 2

K-Number: K162438 · 2017-04-14

ApplicantQuidel Corporation
Decision Date2017-04-14
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia Influenza A+B FIA on Sofia 2 is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K162438. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia Influenza A+B FIA on Sofia 2?

Sofia Influenza A+B FIA on Sofia 2 is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Quidel Corporation. The 510(k) number is K162438.

When did Sofia Influenza A+B FIA on Sofia 2 receive FDA 510(k) clearance?

Sofia Influenza A+B FIA on Sofia 2 received FDA 510(k) clearance on 2017-04-14, under 510(k) number K162438.

Who is the listed applicant for Sofia Influenza A+B FIA on Sofia 2?

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 Influenza A+B FIA on Sofia 2?

The FDA product code for Sofia Influenza A+B FIA on Sofia 2 is PSZ.

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.

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Related Devices (Code: PSZ)

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.

K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBdK192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC

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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