VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14— 510(k) K042479

Name: FDA 510(k) clearance K042479
Creator: U.S. Food and Drug Administration
Published: 2005-01-06

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K042479 for VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14, Substantially Equivalent on 2005-01-06. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Device name as filed: VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2004-09-13
Decision date: 2005-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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