PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST


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

Correspodent Contact erika b ammirati
Regulation Number 862.3100
Classification Product Code
OIW  
Date Received 03/31/2008
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