FDA 510(k)

BioSign Flu A+B

K-Number: K182157 · 2018-09-18

Decision Date2018-09-18

Product CodePSZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BioSign Flu A+B is a medical device manufactured by Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2018-09-18 under approval number K182157. 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 BioSign Flu A+B?

BioSign Flu A+B is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Princeton BioMeditech Corp.. The 510(k) number is K182157.

When was BioSign Flu A+B approved by the FDA?

BioSign Flu A+B received FDA 510(k) clearance on 2018-09-18, under approval number K182157.

What company makes BioSign Flu A+B?

BioSign Flu A+B is manufactured by Princeton BioMeditech Corp..

What is the FDA product code for BioSign Flu A+B?

The FDA product code for BioSign Flu A+B is PSZ.

Other Devices by Princeton BioMeditech Corp.

K251538Status COVID-19/Flu A&B

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO K153012Sofia Influenza A+B FIAQuidel Corporation K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.