Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALERE BINAXNOW INFLUENZA A & B CARD

K-Number: K133411 · 2013-12-05

ApplicantAlere Scarborough, Inc D/B/A Binax, Inc.
Decision Date2013-12-05
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALERE BINAXNOW INFLUENZA A & B CARD is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc D/B/A Binax, Inc.. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K133411. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALERE BINAXNOW INFLUENZA A & B CARD?

ALERE BINAXNOW INFLUENZA A & B CARD is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is Alere Scarborough, Inc D/B/A Binax, Inc.. The 510(k) number is K133411.

When did ALERE BINAXNOW INFLUENZA A & B CARD receive FDA 510(k) clearance?

ALERE BINAXNOW INFLUENZA A & B CARD received FDA 510(k) clearance on 2013-12-05, under 510(k) number K133411.

Who is the listed applicant for ALERE BINAXNOW INFLUENZA A & B CARD?

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

What is the FDA product code for ALERE BINAXNOW INFLUENZA A & B CARD?

The FDA product code for ALERE BINAXNOW INFLUENZA A & B CARD is GNX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alere Scarborough, Inc D/B/A Binax, 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.

K133637ALERE INFLUENZA A & B TESTK103610CLEARVIEW EXACT II INFLUENZA A & B TEST

Related Devices (Code: GNX)

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.

K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131599QUICK VUE INFLUENZAQuidel CorporationK131619QUICKVUE INFLUENZA A+BQuidel Corp.K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC

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.

↑