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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
510(k) Number K101855
Device Name PROFAST+ ASSAY
Applicant
Gen-Probe Prodesse, Inc.
W229n1870 Westwood Dr.
Waukesha,  WI  53186
Applicant Contact KAREN HARRINGTON
Correspondent
Gen-Probe Prodesse, Inc.
W229n1870 Westwood Dr.
Waukesha,  WI  53186
Correspondent Contact KAREN HARRINGTON
Regulation Number866.3332
Classification Product Code
OQW  
Date Received07/01/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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