Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, III, IV

FDA 510(k) K063164 · Ortho-Clinical Diagnostics, Inc.

Substantially Equivalent

510(k) numberK063164

Submission

Device name
Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, III, IV
Applicant
Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
Received
October 18, 2006
Decision date
December 28, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDJ – Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Specialty
Clinical Toxicology

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Questions and answers

When was Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, III, IV cleared by the FDA?

Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, III, IV (K063164) received a 510(k) decision of Substantially Equivalent on December 28, 2006, 71 days after the submission was received.

What is the product code of K063164?

The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.