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FDA 510(k)

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

K-Number: K092223 · 2009-08-12

ApplicantBinax, Inc.
Decision Date2009-08-12
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2009-08-12 under 510(k) number K092223. 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 MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST?

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Binax, Inc.. The 510(k) number is K092223.

When did MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST receive FDA 510(k) clearance?

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST received FDA 510(k) clearance on 2009-08-12, under 510(k) number K092223.

Who is the listed applicant for MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST?

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

What is the FDA product code for MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST?

The FDA product code for MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST is PSZ.

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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.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)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 KitBd

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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