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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 K061508
Device Name OSOM INFLUENZA A&B TEST
Applicant
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Applicant Contact FRED D LASKY
Correspondent
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Correspondent Contact FRED D LASKY
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received06/01/2006
Decision Date 06/12/2006
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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