OC-SENSOR DIANA IFOB TEST— 510(k) K092330

Substantially Equivalent

Polymedco Cancer Diagnostics, LLC

FDA 510(k) clearance K092330 for OC-SENSOR DIANA IFOB TEST, Substantially Equivalent on 2010-01-08. Applicant: Polymedco Cancer Diagnostics, LLC.

Clearance details

Applicant: Polymedco Cancer Diagnostics, LLC
Product code: Code OOX
Advisory panel: Hematology
Date received: 2009-08-04
Decision date: 2010-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.