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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 K092633
Device Name OSOM INFLUENZA A&B TEST , MODEL PN190
Applicant
GENZYME CORPORATION
500 KENDALL STREET
CAMBRIDGE,  MA  02142
Applicant Contact FIL BUENVIAJE
Correspondent
GENZYME CORPORATION
500 KENDALL STREET
CAMBRIDGE,  MA  02142
Correspondent Contact FIL BUENVIAJE
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/27/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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