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FDA 510(k)

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

K-Number: K181853 · 2018-08-08

ApplicantAlere Scarborough, Inc.
Decision Date2018-08-08
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-08-08 under approval number K181853. 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 Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device that received FDA 510(k) clearance on 2018-08-08. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K181853.

When was Alere BinaxNOW Influenza A & B Card 2, Alere Reader approved by the FDA?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader received FDA 510(k) clearance on 2018-08-08, under approval number K181853.

What company makes Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is manufactured by Alere Scarborough, Inc..

What is the FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader is PSZ.

Other Devices by Alere Scarborough, Inc.

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit K161364BinaxNOW G6PD Test K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

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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

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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