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FDA 510(k)

BinaxNOW G6PD Test

K-Number: K161364 · 2016-06-17

ApplicantAlere Scarborough, Inc.
Decision Date2016-06-17
Product CodeJBF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BinaxNOW G6PD Test is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) 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. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K161364.

When did BinaxNOW G6PD Test receive FDA 510(k) clearance?

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

Who is the listed applicant for BinaxNOW G6PD Test?

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

What is the FDA product code for BinaxNOW G6PD Test?

The FDA product code for BinaxNOW G6PD Test is JBF.

Other records listing Alere Scarborough, Inc. 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.

K190204ID NOW Influenza A & B 2K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderK173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitK173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitK171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

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Related Devices (Code: JBF)

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.

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.

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