PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE— 510(k) K092967

Name: FDA 510(k) clearance K092967
Creator: U.S. Food and Drug Administration
Published: 2010-06-08

Substantially Equivalent

Pathwork Diagnostics

FDA 510(k) clearance K092967 for PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE, Substantially Equivalent on 2010-06-08. Applicant: Pathwork Diagnostics. Device class: 2.

Clearance details

Applicant: Pathwork Diagnostics
Product code: Code OIW
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2009-09-25
Decision date: 2010-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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