FDA 510(k)

BinaxNOW G6PD Test

K-Number: K161364 · 2016-06-17

Decision Date2016-06-17

Product CodeJBF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BinaxNOW G6PD Test is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-06-17 under approval number K161364. The device is classified under product code JBF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BinaxNOW G6PD Test?

BinaxNOW G6PD Test is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K161364.

When was BinaxNOW G6PD Test approved by the FDA?

BinaxNOW G6PD Test received FDA 510(k) clearance on 2016-06-17, under approval number K161364.

What company makes BinaxNOW G6PD Test?

BinaxNOW G6PD Test is manufactured by Alere Scarborough, Inc..

What is the FDA product code for BinaxNOW G6PD Test?

The FDA product code for BinaxNOW G6PD Test is JBF.

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 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 K181853Alere BinaxNOW Influenza A & B Card 2, Alere Reader

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Related Devices (Code: JBF)

K201049FINDER G6PDBaebies, 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.