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

Name: FDA 510(k) clearance K092330
Creator: U.S. Food and Drug Administration
Published: 2010-01-08

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. Device class: 2.

Clearance details

Applicant: Polymedco Cancer Diagnostics, LLC
Product code: Code OOX
Device class: Class 2
Regulation: 21 CFR 864.6550
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 ↗

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