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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c. difficile nucleic acid amplification test assay
510(k) Number K113433
Device Name SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
Applicant
FOCUS DIAGNOSTICS, INC.
11331 Valley View Street
CYPRESS,  CA  90630
Applicant Contact SHARON YOUNG
Correspondent
FOCUS DIAGNOSTICS, INC.
11331 Valley View Street
CYPRESS,  CA  90630
Correspondent Contact SHARON YOUNG
Regulation Number866.2660
Classification Product Code
OMN  
Date Received11/21/2011
Decision Date 04/04/2012
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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