Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002;

FDA 510(k) K093611 · Ortho-Clinical Diagnostics, Inc.

Substantially Equivalent

510(k) numberK093611

Submission

Device name
Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002;
Applicant
Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
Received
November 23, 2009
Decision date
April 15, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KHS – Enzymatic, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

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Questions and answers

When was Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002; cleared by the FDA?

Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002; (K093611) received a 510(k) decision of Substantially Equivalent on April 15, 2010, 143 days after the submission was received.

What is the product code of K093611?

The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.