Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) Test
FDA 510(k) K000402 · Drug Detection Devices, Ltd.
510(k) numberK000402
Submission
- Device name
- Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) Test
- Applicant
- Drug Detection Devices, Ltd.
Alpharetta, GA, US - Received
- February 7, 2000
- Decision date
- April 18, 2000
- 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 |
|---|---|---|
| K000452 | Screeners Methamphetamine Test, Drugscreen Dip Methamphetamine TestLAF · Traditional | 04/24/2000SE |
| K000522 | Screeners Barbiturate Test, Drugscreen Dip Barbiturate TestDIS · Traditional | 04/18/2000SE |
| K000400 | Screeners Amphetamine Test, Drugscreen Dip Amphetamine TestDKZ · Traditional | 04/18/2000SE |
| K000350 | Screeners Cocaine Test; Drugscreen Dip Cocaine TestDIO · Traditional | 04/11/2000SE |
| K000449 | Screeners Benzodiazepine (BZD) Test, Drug Screen Dip Benzodiazepine (BZD) TestJXM · Traditional | 04/07/2000SE |
| K000273 | Screeners Opiates Test Drugscreen Dip Opiates TestDJG · Traditional | 04/07/2000SE |
| K992949 | Screeners Marijuana Test, Drugscreen Dip Marijuana TestLDJ · Traditional | 12/27/1999SE |
Questions and answers
When was Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) Test cleared by the FDA?
Screeners Phencyclidine (PCP) Test, Drugscreen Dip Phencyclidine (PCP) Test (K000402) received a 510(k) decision of Substantially Equivalent on April 18, 2000, 71 days after the submission was received.
What is the product code of K000402?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.