Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers
FDA 510(k) K062077 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK062077
Submission
- Device name
- Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- July 21, 2006
- Decision date
- November 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers cleared by the FDA?
Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers (K062077) received a 510(k) decision of Substantially Equivalent on November 22, 2006, 124 days after the submission was received.
What is the product code of K062077?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.