Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and III

FDA 510(k) K043384 · Ortho-Clinical Diagnostics, Inc.

Substantially Equivalent

510(k) numberK043384

Submission

Device name
Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and III
Applicant
Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
Received
December 9, 2004
Decision date
February 7, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDO – Enzymatic Radiochemical Assay, Tobramycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3900
Specialty
Clinical Toxicology

Other 510(k)s with product code LDO

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K841556Heart - Aid Als, 95LDO · Traditional Cardiac Resucitator Corp.07/19/1984SE
K832055Emit Assay and TobramycinLDO · Traditional Syva Co.08/08/1983SE

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Questions and answers

When was Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and III cleared by the FDA?

Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and III (K043384) received a 510(k) decision of Substantially Equivalent on February 7, 2005, 60 days after the submission was received.

What is the product code of K043384?

The FDA product code is LDO – Enzymatic Radiochemical Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.