FDA 510(k) Applications for Medical Device Product Code "LCM"
(Enzyme Immunoassay, Phencyclidine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013096 | ABBOTT LABORATORIES | PHENCYCLIDINE | 03/13/2002 |
| K011730 | ACON LABORATORIES, INC. | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | 08/09/2001 |
| K060353 | ACRO BIOTECH LLC. | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | 05/03/2006 |
| K010047 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | 05/29/2001 |
| K010045 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST | 05/29/2001 |
| K023109 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | 12/16/2002 |
| K012582 | AMEDITECH, INC. | AMEDITECH IMMUTEST DRUG SCREEN PCP | 11/30/2001 |
| K993945 | BIONIKE LABORATORIES, INC. | BIONIKE AQ PHENCYCLIDINE (PCP) TEST | 12/07/1999 |
| K122703 | BIOPHOR DIAGNOSTICS, INC. | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR | 04/25/2013 |
| K972963 | BOEHRINGER MANNHEIM CORP. | MODIFIED CEDIA DAU PCP ASSAY | 09/22/1997 |
| K002272 | BRANAN MEDICAL CORP. | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D | 11/22/2000 |
| K000462 | DADE BEHRING, INC. | URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A | 04/06/2000 |
| K000402 | DRUG DETECTION DEVICES, LTD. | SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST | 04/18/2000 |
| K963233 | EDITEK, INC. | EZ-SCREEN PROFILE | 10/31/1996 |
| K963692 | EDITEK, INC. | VERDICT PCP | 12/10/1996 |
| K142044 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | 08/25/2014 |
| K152176 | Immunalysis Corporation | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 09/04/2015 |
| K181135 | Immunalysis Corporation | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | 01/24/2019 |
| K203489 | Immunalysis Corporation | SEFRIA PCP Oral Fluid Enzyme Immunoassay | 04/20/2021 |
| K020254 | Lin-Zhi International, Inc. | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | 05/10/2002 |
| K002776 | MEDTOX DIAGNOSTICS, INC. | MODIFICATION TO PROFILE -II | 09/28/2000 |
| K991505 | MICRODIAGNOSTICS, INC. | MICRO-STRIP FOR PHENCYCLIDINE METABOLITES | 08/05/1999 |
| K101746 | MICROGENICS CORP. | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | 04/08/2011 |
| K131181 | OMEGA LABORATORIES, INC. | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | 06/25/2013 |
| K101059 | OMEGA LABORATORIES, INC. | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | 07/12/2010 |
| K982801 | ORASURE TECHNOLOGIES, INC. | AUTO-LYTE PCP EIA, MODEL #1254U | 11/04/1998 |
| K000399 | ORASURE TECHNOLOGIES, INC. | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | 05/15/2000 |
| K062094 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V | 11/22/2006 |
| K012107 | PAN PROBE BIOTECH, INC. | LIVESURE PHENECYCLINE (PCP) SCREEN TESTS | 07/20/2001 |
| K994236 | PHAMATECH | AT HOME DRUG TEST, MODEL 9133 | 12/30/1999 |
| K010651 | PHAMATECH | AT HOME DRUG TEST, MODEL 9133 T | 03/30/2001 |
| K974582 | PHAMATECH | QUICKSCREEN ONE STEP PCP SCREENING TEST | 02/04/1998 |
| K041578 | PHAMATECH | QUICKSCREEN, MODELS 9177X AND 9178X | 09/10/2004 |
| K961266 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN, BIOSIGN PCP | 05/31/1996 |
| K111928 | PSYCHEMEDICS CORP. | PSYCHEMEDICS PHENCYCLIDINE EIA | 05/01/2012 |
| K212952 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | 04/18/2022 |
| K080431 | QUANTRX BIOMEDICAL CORPORATION | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | 01/08/2009 |
| K042726 | QUEST DIAGNOSTICS, INC. | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | 07/28/2005 |
| K043071 | RANDOX LABORATORIES, LTD. | RANDOX PHENCYCLIDINE ASSAY | 01/27/2005 |
| K991698 | REDWOOD BIOTECH, INC. | REDI-TEST PCP | 08/25/1999 |
| K964355 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP 5 (MODIFICATION) | 12/13/1996 |
| K093989 | Roche Diagnostics | ORAL FLUID PHENCYCLIDINE | 01/25/2011 |
| K043305 | ROCHE DIAGNOSTICS CORP. | ONLINE DAT PHENCYCLIDINE PLUS | 01/10/2005 |
| K994017 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 | 01/27/2000 |
| K994030 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP 5, CAT. 07 6481 7 | 01/27/2000 |
| K994020 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 | 01/27/2000 |
| K163220 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Phencyclidine (Pcp) | 04/06/2017 |
| K983790 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE | 03/01/1999 |
| K981292 | SYNTRON BIORESEARCH, INC. | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | 05/26/1998 |
| K981019 | SYNTRON BIORESEARCH, INC. | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | 05/07/1998 |
| K993983 | SYVA CO. | SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL | 01/27/2000 |
| K011161 | SYVA CO., DADE BEHRING, INC. | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 | 05/15/2001 |
| K981363 | TCPI, INC. | ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST | 12/22/1998 |
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