CLEARVIEW EXACT II INFLUENZA A & B TEST— 510(k) K092349

Name: FDA 510(k) clearance K092349
Creator: U.S. Food and Drug Administration
Published: 2010-05-10

Substantially Equivalent

Inverness Medical, Inc.

FDA 510(k) clearance K092349 for CLEARVIEW EXACT II INFLUENZA A & B TEST, Substantially Equivalent on 2010-05-10. Applicant: Inverness Medical, Inc.. Device class: 2.

Clearance details

Applicant: Inverness Medical, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2009-08-04
Decision date: 2010-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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