VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III— 510(k) K042520

Name: FDA 510(k) clearance K042520
Creator: U.S. Food and Drug Administration
Published: 2004-11-30

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K042520 for VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III, Substantially Equivalent on 2004-11-30. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 2004-09-16
Decision date: 2004-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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