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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K092349
Device Name CLEARVIEW EXACT II INFLUENZA A & B TEST
Applicant
Inverness Medical, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Anne Jepson
Correspondent
Inverness Medical, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Anne Jepson
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/04/2009
Decision Date 05/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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