Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, III, IV, & V
FDA 510(k) K062094 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK062094
Submission
- Device name
- Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, III, IV, & V
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- July 24, 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
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
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| K142044 | CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineLCM · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/25/2014SE |
| K131181 | Omega Laboratories Hair Drug Screening Assay PhencyclidineLCM · Traditional | Omega Laboratories, Inc. | 06/25/2013SE |
| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | Biophor Diagnostics, Inc. | 04/25/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
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Questions and answers
When was Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, III, IV, & V cleared by the FDA?
Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, III, IV, & V (K062094) received a 510(k) decision of Substantially Equivalent on November 22, 2006, 121 days after the submission was received.
What is the product code of K062094?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.