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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 K080896
Device Name PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
Original Applicant
PATHWORK DIAGNOSTICS, INC.
1196 borregas ave.
suite 200
sunnyvale,  CA  94089
Original Contact erika b ammirati
Regulation Number862.3100
Classification Product Code
OIW  
Date Received03/31/2008
Decision Date 07/30/2008
Decision substantially equivalent - with limitations (SU)
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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