THE VITROS 5,1 FS CHEMISTRY SYSTEM— 510(k) K041764

Name: FDA 510(k) clearance K041764
Creator: U.S. Food and Drug Administration
Published: 2004-09-09

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K041764 for THE VITROS 5,1 FS CHEMISTRY SYSTEM, Substantially Equivalent on 2004-09-09. Applicant: Ortho-Clinical Diagnostics. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2004-06-30
Decision date: 2004-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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