LCM · Enzyme Immunoassay, Phencyclidine
· Class U
Overview
| Product Code | LCM |
|---|---|
| Device Name | Enzyme Immunoassay, Phencyclidine |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 88)
Showing 20 most recent of 88 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Psychemedics Corporation | Apr 18, 2022 | SESE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | Apr 20, 2021 | SESE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | Jan 24, 2019 | SESE |
| K163220 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | Apr 6, 2017 | SESE |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Sep 4, 2015 | SESE |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | Guangzhou Wondfo Biotech Co., Ltd. | Aug 25, 2014 | SESE |
| K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | Omega Laboratories, Inc. | Jun 25, 2013 | SESE |
| K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR | Biophor Diagnostics, Inc. | Apr 25, 2013 | SESE |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | Psychemedics Corp. | May 1, 2012 | SESE |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Microgenics Corp. | Apr 8, 2011 | SESE |
| K093989 | ORAL FLUID PHENCYCLIDINE | Roche Diagnostics | Jan 25, 2011 | SESE |
| K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | Omega Laboratories, Inc. | Jul 12, 2010 | SESE |
| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Quantrx Biomedical Corporation | Jan 8, 2009 | SESE |
| K062094 | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V | Ortho-Clinical Diagnostics, Inc. | Nov 22, 2006 | SESE |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | Acro Biotech, LLC | May 3, 2006 | SESE |
| K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | Quest Diagnostics, Inc. | Jul 28, 2005 | SESE |
| K043071 | RANDOX PHENCYCLIDINE ASSAY | Randox Laboratories, Ltd. | Jan 27, 2005 | SESE |
| K043305 | ONLINE DAT PHENCYCLIDINE PLUS | Roche Diagnostics Corp. | Jan 10, 2005 | SESE |
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | Phamatech | Sep 10, 2004 | SESE |
| K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | Amedica Biotech, Inc. | Dec 16, 2002 | SESE |
Top Applicants
- Syva Co. — 10 clearances
- Abbott Laboratories — 5 clearances
- Phamatech — 4 clearances
- Roche Diagnostic Systems, Inc. — 4 clearances
- Roche Diagnostics Corp. — 4 clearances
