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FDA 510(k)

Sofia Influenza A+B FIA

K-Number: K153012 · 2016-01-12

ApplicantQuidel Corporation
Decision Date2016-01-12
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia Influenza A+B FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K153012. 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?

Sofia Influenza A+B FIA is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Quidel Corporation. The 510(k) number is K153012.

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

Sofia Influenza A+B FIA received FDA 510(k) clearance on 2016-01-12, under 510(k) number K153012.

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

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?

The FDA product code for Sofia Influenza A+B FIA 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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