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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name software, similarity score algorithm, tissue of origin for malignant tumor types
510(k) Number K092967
Device Name PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
Original Applicant
PATHWORK DIAGNOSTICS
595 penobscot drive
redwood city,  CA  94063
Original Contact anna longwell
Regulation Number862.3100
Classification Product Code
OIW  
Date Received09/25/2009
Decision Date 06/08/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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