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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 K100148
Device Name SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
Applicant
FOCUS DIAGNOSTICS, INC.
11331 VALLEY VIEW ST.
CYPRESS,  CA  90630
Applicant Contact TARA VIVIANI
Correspondent
FOCUS DIAGNOSTICS, INC.
11331 VALLEY VIEW ST.
CYPRESS,  CA  90630
Correspondent Contact TARA VIVIANI
Regulation Number866.3332
Classification Product Code
OQW  
Date Received01/19/2010
Decision Date 05/24/2010
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
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