Quest Diagnostics Haircheck-Dt (PCP
FDA 510(k) K042726 · Quest Diagnostics, Inc.
510(k) numberK042726
Submission
- Device name
- Quest Diagnostics Haircheck-Dt (PCP
- Applicant
- Quest Diagnostics, Inc.
Las Vegas, NV, US - Received
- October 1, 2004
- Decision date
- July 28, 2005
- 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
Other 510(k)s with product code LCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | Psychemedics Corporation | 04/18/2022SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 04/20/2021SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 01/24/2019SE |
| K163220 | Atellica CH Phencyclidine (Pcp)LCM · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/06/2017SE |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM · Traditional | Immunalysis Corporation | 09/04/2015SE |
| 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 |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | 11/18/2016SE |
| K080381 | Quest Diagnostics Methamphetamine Micro-Plate EiaLAF · Traditional | 06/25/2008SE |
| K062929 | Quest Diagnostics Urine Cocaine Metabolite EiaDIO · Traditional | 12/18/2006SE |
| K051161 | Quest Diagnostics Haircheck-Dt (Amphetamines)DKZ · Traditional | 11/22/2005SE |
| K042725 | Quest Diagnostics Haircheck-Dt (Opiates)DJG · Traditional | 07/06/2005SE |
| K040257 | Quest Diagnostics Haircheck-Dt (THC)LDJ · Traditional | 06/14/2004SE |
| K023626 | Aml Haircheck-Dt (Cocaine)DIO · Traditional | 09/29/2003SE |
Questions and answers
When was Quest Diagnostics Haircheck-Dt (PCP cleared by the FDA?
Quest Diagnostics Haircheck-Dt (PCP (K042726) received a 510(k) decision of Substantially Equivalent on July 28, 2005, 300 days after the submission was received.
What is the product code of K042726?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.