Product code LCM
- Device name
- Enzyme Immunoassay, Phencyclidine
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Psychemedics Corporation | 2022-04-18 |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021-04-20 |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2019-01-24 |
| K163220 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | 2017-04-06 |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2015-09-04 |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | Guangzhou Wondfo Biotech Co., Ltd. | 2014-08-25 |
| K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | Omega Laboratories, Inc. | 2013-06-25 |
| K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR | Biophor Diagnostics, Inc. | 2013-04-25 |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | Psychemedics Corp. | 2012-05-01 |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Microgenics Corp. | 2011-04-08 |
| K093989 | ORAL FLUID PHENCYCLIDINE | Roche Diagnostics | 2011-01-25 |
| K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | Omega Laboratories, Inc. | 2010-07-12 |
| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Quantrx Biomedical Corporation | 2009-01-08 |
| K062094 | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | Acro Biotech, LLC | 2006-05-03 |
| K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | Quest Diagnostics, Inc. | 2005-07-28 |
| K043071 | RANDOX PHENCYCLIDINE ASSAY | Randox Laboratories, Ltd. | 2005-01-27 |
| K043305 | ONLINE DAT PHENCYCLIDINE PLUS | Roche Diagnostics Corp. | 2005-01-10 |
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | Phamatech | 2004-09-10 |
| K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | Amedica Biotech, Inc. | 2002-12-16 |
| K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | Lin-Zhi International, Inc. | 2002-05-10 |
| K013096 | PHENCYCLIDINE | Abbott Laboratories | 2002-03-13 |
| K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP | Ameditech, Inc. | 2001-11-30 |
| K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | ACON Laboratories, Inc. | 2001-08-09 |
| K012107 | LIVESURE PHENECYCLINE (PCP) SCREEN TESTS | Pan Probe Biotech, Inc. | 2001-07-20 |
| K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K011161 | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 | Syva Co., Dade Behring, Inc. | 2001-05-15 |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | Phamatech | 2001-03-30 |
| K002272 | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D | Branan Medical Corp. | 2000-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00894175000091 | QMedix™ | Diagnostic Automation, Inc. | 2026-09-30 |
| 00810173657556 | Healgen Scientific | Healgen Scientific Limited Liability Company | 2026-09-28 |
| 00810173657686 | Healgen Scientific | Healgen Scientific Limited Liability Company | 2026-09-28 |
| 00810173657693 | Healgen Scientific | Healgen Scientific Limited Liability Company | 2026-09-28 |
| 00810173658102 | Healgen Scientific | Healgen Scientific Limited Liability Company | 2026-09-28 |
| B2986080760 | DrugCheck | Express Diagnostic Int'l, Inc. | 2026-09-24 |
| 00817405024247 | iScreen™ | Instant Technologies, Inc. | 2026-08-01 |
| 00810173656719 | Healgen | Healgen Scientific Limited Liability Company | 2026-07-31 |
| 00841824104167 | ECOII | W.H.P.M. INC. | 2026-07-07 |
| 00810174471229 | Prime Screen® | WONDFO USA CO., LTD. | 2026-06-26 |
| 00810173656771 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656788 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656764 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656740 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656733 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656726 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656757 | Healgen | Healgen Scientific Limited Liability Company | 2026-06-03 |
| 00810173656702 | Accurate | Healgen Scientific Limited Liability Company | 2026-06-02 |
| 10850013035530 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035684 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035677 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035424 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035417 | Identify®Diagnostics Drug Test Dips | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035400 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10612479255293 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10612479255323 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10612479258430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10694644100010 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100034 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100058 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |