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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
Model MOL2500
Device Name SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
Original Applicant
FOCUS DIAGNOSTICS, INC.
11331 valley view st.
cypress,  CA  90630
Original Contact tara viviani
Regulation Number866.3332
Classification Product Code
OQW  
Date Received01/19/2010
Decision Date 05/24/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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