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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 K120489
Device Name TISSUE OF ORIGIN TEST KIT FFPE
Applicant
PATHWORK DIAGNOSTICS, INC.
1900 embarcadero road
palo alto,  CA  94303
Applicant Contact anna longwell
Correspondent
PATHWORK DIAGNOSTICS, INC.
1900 embarcadero road
palo alto,  CA  94303
Correspondent Contact anna longwell
Regulation Number862.3100
Classification Product Code
OIW  
Date Received02/17/2012
Decision Date 05/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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