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FDA 510(k) Application Details - K120489
Device Classification Name
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
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510(K) Number
K120489
Device Name
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Applicant
PATHWORK DIAGNOSTICS, INC.
1900 EMBARCADERO ROAD
PALO ALTO, CA 94303 US
Other 510(k) Applications for this Company
Contact
ANNA LONGWELL
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
OIW
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More FDA Info for this Product Code
Date Received
02/17/2012
Decision Date
05/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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