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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
Applicant
PATHWORK DIAGNOSTICS, INC.
1196 BORREGAS AVE.
SUITE 200
SUNNYVALE,  CA  94089
Applicant Contact Erika B Ammirati
Correspondent
PATHWORK DIAGNOSTICS, INC.
1196 BORREGAS AVE.
SUITE 200
SUNNYVALE,  CA  94089
Correspondent Contact Erika B Ammirati
Regulation Number862.3100
Classification Product Code
OIW  
Date Received03/31/2008
Decision Date 07/30/2008
Decision SE - With Limitations (SESU)
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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