FDA.reportPublic FDA data

510(k) K092967

Device
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
Applicant
PATHWORK DIAGNOSTICS
510(k) number
K092967
Product code
OIW  
Decision
Substantially Equivalent (SESE)
Decision date
2010-06-08
Date received
2009-09-25
Regulation
862.3100
Classification name
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Medical specialty
Toxicology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANNA LONGWELL
Address
595 Penobscot Dr. Redwood City CA US 94063 94063

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc.2018-03-15
K120489TISSUE OF ORIGIN TEST KIT FFPEPathwork Diagnostics, Inc.2012-05-17
K080896PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTPathwork Diagnostics, Inc.2008-07-30

Legacy Summary#

summary

FDA Review#

Decision Summary