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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
Applicant
Pathwork Diagnostics
595 Penobscot Dr.
Redwood City,  CA  94063
Applicant Contact ANNA LONGWELL
Correspondent
Pathwork Diagnostics
595 Penobscot Dr.
Redwood City,  CA  94063
Correspondent Contact ANNA LONGWELL
Regulation Number862.3100
Classification Product Code
OIW  
Date Received09/25/2009
Decision Date 06/08/2010
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
Predetermined Change
Control Plan Authorized		 No
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