OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044— 510(k) K061730

Name: FDA 510(k) clearance K061730
Creator: U.S. Food and Drug Administration
Published: 2006-08-04

Substantially Equivalent

Osmetech, Inc.

FDA 510(k) clearance K061730 for OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044, Substantially Equivalent on 2006-08-04. Applicant: Osmetech, Inc.. Device class: 2.

Clearance details

Applicant: Osmetech, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2006-06-20
Decision date: 2006-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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