VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20— 510(k) K042475

Name: FDA 510(k) clearance K042475
Creator: U.S. Food and Drug Administration
Published: 2004-11-10

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K042475 for VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20, Substantially Equivalent on 2004-11-10. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Device name as filed: VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2004-09-13
Decision date: 2004-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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