Product code LCM ยท Class U
Enzyme Immunoassay, Phencyclidine
0510(k)s in 12 months (88 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in LCM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2022 | K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair Psychemedics Corporation | LCM |
| Apr 20, 2021 | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LCM |
| Jan 24, 2019 | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LCM |
| Apr 6, 2017 | K163220 | Atellica CH Phencyclidine (Pcp) Siemens Healthcare Diagnostics, Inc. | LCM |
| Sep 4, 2015 | K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | LCM |
| Aug 25, 2014 | K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd. | LCM |
| Jun 25, 2013 | K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE Omega Laboratories, Inc. | LCM |
| Apr 25, 2013 | K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR Biophor Diagnostics, Inc. | LCM |
| May 1, 2012 | K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA Psychemedics Corp. | LCM |
| Apr 8, 2011 | K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY Microgenics Corp. | LCM |
| Jan 25, 2011 | K093989 | ORAL FLUID PHENCYCLIDINE Roche Diagnostics | LCM |
| Jul 12, 2010 | K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE Omega Laboratories, Inc. | LCM |
| Jan 8, 2009 | K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 Quantrx Biomedical Corporation | LCM |
| Nov 22, 2006 | K062094 | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V Ortho-Clinical Diagnostics, Inc. | LCM |
| May 3, 2006 | K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 Acro Biotech, LLC | LCM |
| Jul 28, 2005 | K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP Quest Diagnostics, Inc. | LCM |
| Jan 27, 2005 | K043071 | RANDOX PHENCYCLIDINE ASSAY Randox Laboratories, Ltd., GB | LCM |
| Jan 10, 2005 | K043305 | ONLINE DAT PHENCYCLIDINE PLUS Roche Diagnostics Corp. | LCM |
| Sep 10, 2004 | K041578 | QUICKSCREEN, MODELS 9177X AND 9178X Phamatech | LCM |
| Dec 16, 2002 | K023109 | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST Amedica Biotech, Inc. | LCM |
| May 10, 2002 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 Lin-Zhi International, Inc. | LCM |
| Mar 13, 2002 | K013096 | PHENCYCLIDINE Abbott Laboratories | LCM |
| Nov 30, 2001 | K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP Ameditech, Inc. | LCM |
| Aug 9, 2001 | K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE ACON Laboratories, Inc. | LCM |
| Jul 20, 2001 | K012107 | LIVESURE PHENECYCLINE (PCP) SCREEN TESTS Pan Probe Biotech, Inc. | LCM |
| May 29, 2001 | K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | LCM |
| May 29, 2001 | K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | LCM |
| May 15, 2001 | K011161 | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 Syva Co., Dade Behring, Inc. | LCM |
| Mar 30, 2001 | K010651 | AT HOME DRUG TEST, MODEL 9133 T Phamatech | LCM |
| Nov 22, 2000 | K002272 | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D Branan Medical Corp. | LCM |
| Sep 28, 2000 | K002776 | MODIFICATION TO PROFILE -II Medtox Diagnostics, Inc. | LCM |
| May 15, 2000 | K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 OraSure Technologies, Inc. | LCM |
| Apr 18, 2000 | K000402 | SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST Drug Detection Devices, Ltd. | LCM |
| Apr 6, 2000 | K000462 | URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A Dade Behring, Inc. | LCM |
| Jan 27, 2000 | K994030 | ONTRAK TESTCUP 5, CAT. 07 6481 7 Roche Diagnostics Corp. | LCM |
| Jan 27, 2000 | K994020 | ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 Roche Diagnostics Corp. | LCM |
| Jan 27, 2000 | K994017 | ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 Roche Diagnostics Corp. | LCM |
| Jan 27, 2000 | K993983 | SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL Syva Co. | LCM |
| Dec 30, 1999 | K994236 | AT HOME DRUG TEST, MODEL 9133 Phamatech | LCM |
| Dec 7, 1999 | K993945 | BIONIKE AQ PHENCYCLIDINE (PCP) TEST Bionike Laboratories, Inc. | LCM |
| Aug 25, 1999 | K991698 | REDI-TEST PCP Redwood Biotech, Inc. | LCM |
| Aug 5, 1999 | K991505 | MICRO-STRIP FOR PHENCYCLIDINE METABOLITES Microdiagnostics, Inc. | LCM |
| Mar 1, 1999 | K983790 | VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE Sun Biomedical Laboratories, Inc. | LCM |
| Dec 22, 1998 | K981363 | ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST Tcpi, Inc. | LCM |
| Nov 4, 1998 | K982801 | AUTO-LYTE PCP EIA, MODEL #1254U OraSure Technologies, Inc. | LCM |
| May 26, 1998 | K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST Syntron Bioresearch, Inc. | LCM |
| May 7, 1998 | K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST Syntron Bioresearch, Inc. | LCM |
| Feb 4, 1998 | K974582 | QUICKSCREEN ONE STEP PCP SCREENING TEST Phamatech | LCM |
| Sep 22, 1997 | K972963 | MODIFIED CEDIA DAU PCP ASSAY Boehringer Mannheim Corp. | LCM |
| Dec 13, 1996 | K964355 | ONTRAK TESTCUP 5 (MODIFICATION) Roche Diagnostic Systems, Inc. | LCM |
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