Livesure Phenecycline (PCP) Screen Tests
FDA 510(k) K012107 · Pan Probe Biotech, Inc.
510(k) numberK012107
Submission
- Device name
- Livesure Phenecycline (PCP) Screen Tests
- Applicant
- Pan Probe Biotech, Inc.
San Diego, CA, US - Received
- July 5, 2001
- Decision date
- July 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K020968 | Livesure HCG Urinary Pregnancy Test Strip and Test CardJHI · Traditional | 07/15/2002SE |
| K013796 | Livesure Methadone Screen TestsDJR · Traditional | 11/26/2001SE |
| K012133 | Livesure Barbiturates Screen TestDIS · Traditional | 07/20/2001SE |
| K012131 | Livesure Benzodiazepines Screen TestsJXM · Traditional | 07/20/2001SE |
| K011610 | Livesure Methamphetamine Screen TestsLAF · Traditional | 06/08/2001SE |
| K011609 | Livesure Amphetamine Screen TestDKZ · Traditional | 06/08/2001SE |
| K010967 | Livesure Cocaine Screen TestDIO · Traditional | 04/17/2001SE |
| K011011 | Livesure Morphine Screen TestDOE · Traditional | 04/13/2001SE |
| K010001 | Livesure THC Screen TestLDJ · Traditional | 02/05/2001SE |
Questions and answers
When was Livesure Phenecycline (PCP) Screen Tests cleared by the FDA?
Livesure Phenecycline (PCP) Screen Tests (K012107) received a 510(k) decision of Substantially Equivalent on July 20, 2001, 15 days after the submission was received.
What is the product code of K012107?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.