VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III— 510(k) K052819

Name: FDA 510(k) clearance K052819
Creator: U.S. Food and Drug Administration
Published: 2005-12-23

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K052819 for VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III, Substantially Equivalent on 2005-12-23. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code DEM
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 2005-10-04
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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