VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV— 510(k) K062123

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K062123 for VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV, Substantially Equivalent on 2006-11-16. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2006-07-25
Decision date: 2006-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho-Clinical Diagnostics, Inc.

Recalls naming K062123

K-number listed on FDA's recall record

Z-0817-2014 — VITROS Chemistry Products COCM ReagentClass II·Terminated·Ortho-Clinical Diagnostics·20131004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062123.

Data sourced from openFDA. This site is unofficial and independent of the FDA.