TISSUE OF ORIGIN TEST KIT FFPE— 510(k) K120489

Name: FDA 510(k) clearance K120489
Creator: U.S. Food and Drug Administration
Published: 2012-05-17

Substantially Equivalent

Pathwork Diagnostics, Inc.

FDA 510(k) clearance K120489 for TISSUE OF ORIGIN TEST KIT FFPE, Substantially Equivalent on 2012-05-17. Applicant: Pathwork Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Pathwork Diagnostics, Inc.
Product code: Code OIW
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2012-02-17
Decision date: 2012-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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