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FDA 510(k)

CLEARVIEW EXACT II INFLUENZA A & B TEST

K-Number: K103610 · 2011-01-06

ApplicantAlere Scarborough, Inc D/B/A Binax, Inc.
Decision Date2011-01-06
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW EXACT II INFLUENZA A & B TEST 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 2011-01-06 under 510(k) number K103610. 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 CLEARVIEW EXACT II INFLUENZA A & B TEST?

CLEARVIEW EXACT II INFLUENZA A & B TEST is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Alere Scarborough, Inc D/B/A Binax, Inc.. The 510(k) number is K103610.

When did CLEARVIEW EXACT II INFLUENZA A & B TEST receive FDA 510(k) clearance?

CLEARVIEW EXACT II INFLUENZA A & B TEST received FDA 510(k) clearance on 2011-01-06, under 510(k) number K103610.

Who is the listed applicant for CLEARVIEW EXACT II INFLUENZA A & B TEST?

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 CLEARVIEW EXACT II INFLUENZA A & B TEST?

The FDA product code for CLEARVIEW EXACT II INFLUENZA A & B TEST is PSZ.

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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 TESTK133411ALERE BINAXNOW INFLUENZA A & B CARD

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.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd

Official Source

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