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FDA 510(k)

BINAXNOW INFLUENZA A & B TEST

K-Number: K062109 · 2006-11-09

ApplicantBinax, Inc.
Decision Date2006-11-09
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BINAXNOW INFLUENZA A & B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2006-11-09 under 510(k) number K062109. 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 BINAXNOW INFLUENZA A & B TEST?

BINAXNOW INFLUENZA A & B TEST is a medical device that received FDA 510(k) clearance on 2006-11-09. The listed applicant is Binax, Inc.. The 510(k) number is K062109.

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

BINAXNOW INFLUENZA A & B TEST received FDA 510(k) clearance on 2006-11-09, under 510(k) number K062109.

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

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

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

The FDA product code for BINAXNOW INFLUENZA A & B TEST is PSZ.

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Related Devices (Code: PSZ)

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.

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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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