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Enzyme Immunoassay, Phencyclidine

FDA product code LCM · 86 cleared devices

Class U Unknown

Review panel: TX
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-06-15 – 2022-04-18

LCM 2022-04-18

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

Applicant Psychemedics Corporation

K number K212952

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LCM 2021-04-20

SEFRIA PCP Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K number K203489

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LCM 2019-01-24

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K number K181135

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LCM 2017-04-06

Atellica CH Phencyclidine (Pcp)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K163220

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LCM 2013-06-25

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE

Applicant Omega Laboratories, Inc.

K number K131181

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LCM 2013-04-25

RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR

Applicant Biophor Diagnostics, Inc.

K number K122703

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LCM 2012-05-01

PSYCHEMEDICS PHENCYCLIDINE EIA

Applicant Psychemedics Corp.

K number K111928

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LCM 2011-04-08

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

Applicant Microgenics Corp.

K number K101746

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LCM 2011-01-25

ORAL FLUID PHENCYCLIDINE

Applicant Roche Diagnostics

K number K093989

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LCM 2010-07-12

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

Applicant Omega Laboratories, Inc.

K number K101059

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LCM 2009-01-08

RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054

Applicant Quantrx Biomedical Corporation

K number K080431

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LCM 2006-11-22

VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V

Applicant Ortho-Clinical Diagnostics, Inc.

K number K062094

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LCM 2006-05-03

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

Applicant Acro Biotech, LLC

K number K060353

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LCM 2005-07-28

QUEST DIAGNOSTICS HAIRCHECK-DT (PCP

Applicant Quest Diagnostics, Inc.

K number K042726

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LCM 2005-01-27

RANDOX PHENCYCLIDINE ASSAY

Applicant Randox Laboratories, Ltd.

K number K043071

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LCM 2005-01-10

ONLINE DAT PHENCYCLIDINE PLUS

Applicant Roche Diagnostics Corp.

K number K043305

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LCM 2004-09-10

QUICKSCREEN, MODELS 9177X AND 9178X

Applicant Phamatech

K number K041578

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LCM 2002-12-16

AMEDICA DRUG SCREEN PHENCYCLIDINE TEST

Applicant Amedica Biotech, Inc.

K number K023109

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LCM 2002-05-10

PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011

Applicant Lin-Zhi International, Inc.

K number K020254

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LCM 2002-03-13

PHENCYCLIDINE

Applicant Abbott Laboratories

K number K013096

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LCM 2001-11-30

AMEDITECH IMMUTEST DRUG SCREEN PCP

Applicant Ameditech, Inc.

K number K012582

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LCM 2001-08-09

ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K011730

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LCM 2001-07-20

LIVESURE PHENECYCLINE (PCP) SCREEN TESTS

Applicant Pan Probe Biotech, Inc.

K number K012107

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LCM 2001-05-29

INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST

Applicant Alfa Scientific Designs, Inc.

K number K010047

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LCM 2001-05-29

INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST

Applicant Alfa Scientific Designs, Inc.

K number K010045

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LCM 2001-05-15

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

Applicant Syva Co., Dade Behring, Inc.

K number K011161

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LCM 2001-03-30

AT HOME DRUG TEST, MODEL 9133 T

Applicant Phamatech

K number K010651

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LCM 2000-11-22

BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D

Applicant Branan Medical Corp.

K number K002272

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LCM 2000-09-28

MODIFICATION TO PROFILE -II

Applicant Medtox Diagnostics, Inc.

K number K002776

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LCM 2000-05-15

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

Applicant OraSure Technologies, Inc.

K number K000399

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LCM 2000-04-18

SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST

Applicant Drug Detection Devices, Ltd.

K number K000402

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LCM 2000-04-06

URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

Applicant Dade Behring, Inc.

K number K000462

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LCM 2000-01-27

ONTRAK TESTCUP 5, CAT. 07 6481 7

Applicant Roche Diagnostics Corp.

K number K994030

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LCM 2000-01-27

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2

Applicant Roche Diagnostics Corp.

K number K994020

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LCM 2000-01-27

ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1

Applicant Roche Diagnostics Corp.

K number K994017

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LCM 2000-01-27

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL

Applicant Syva Co.

K number K993983

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LCM 1999-12-30

AT HOME DRUG TEST, MODEL 9133

Applicant Phamatech

K number K994236

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LCM 1999-12-07

BIONIKE AQ PHENCYCLIDINE (PCP) TEST

Applicant Bionike Laboratories, Inc.

K number K993945

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LCM 1999-08-25

REDI-TEST PCP

Applicant Redwood Biotech, Inc.

K number K991698

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LCM 1999-08-05

MICRO-STRIP FOR PHENCYCLIDINE METABOLITES

Applicant Microdiagnostics, Inc.

K number K991505

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LCM 1999-03-01

VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE

Applicant Sun Biomedical Laboratories, Inc.

K number K983790

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LCM 1998-12-22

ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST

Applicant Tcpi, Inc.

K number K981363

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LCM 1998-11-04

AUTO-LYTE PCP EIA, MODEL #1254U

Applicant OraSure Technologies, Inc.

K number K982801

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LCM 1998-05-26

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST

Applicant Syntron Bioresearch, Inc.

K number K981292

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LCM 1998-05-07

QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST

Applicant Syntron Bioresearch, Inc.

K number K981019

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LCM 1998-02-04

QUICKSCREEN ONE STEP PCP SCREENING TEST

Applicant Phamatech

K number K974582

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LCM 1997-09-22

MODIFIED CEDIA DAU PCP ASSAY

Applicant Boehringer Mannheim Corp.

K number K972963

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LCM 1996-12-13

ONTRAK TESTCUP 5 (MODIFICATION)

Applicant Roche Diagnostic Systems, Inc.

K number K964355

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LCM 1996-12-10

VERDICT PCP

Applicant Editek, Inc.

K number K963692

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LCM 1996-10-31

EZ-SCREEN PROFILE

Applicant Editek, Inc.

K number K963233

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LCM 1996-05-31

ACCUSIGN, BIOSIGN PCP

Applicant Princeton BioMeditech Corp.

K number K961266

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LCM 1995-10-26

AXSYM PHENCYCLIDINE II

Applicant Abbott Laboratories

K number K953534

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LCM 1995-03-20

URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K950183

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LCM 1995-02-22

EMIT IIC PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K935191

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LCM 1995-01-17

CEDIA(R) DAU PCP ASSAY

Applicant Microgenics Corp.

K number K946059

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LCM 1994-12-07

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM

Applicant Beckman-Diagnostic Systems Group

K number K944605

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LCM 1994-09-09

EZ-SCREEN:PCP

Applicant Editek, Inc.

K number K943711

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LCM 1994-04-12

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400

Applicant U.S. Drug Testing, Inc.

K number K935629

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LCM 1994-04-05

CEDIA(R) DAU PCP ASSAY

Applicant Microgenics Corp.

K number K935650

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LCM 1993-12-29

PHENCYCLIDINE EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K935320

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LCM 1992-12-11

SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K924751

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LCM 1992-11-02

STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA

Applicant Solarcare Technologies Corp,Inc.

K number K924462

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LCM 1992-07-08

MICROLINE SCREEN FOR PHENCYCLIDINE

Applicant Drug Screening Systems, Inc.

K number K921651

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LCM 1992-03-18

PHENCYCLIDINE EIA ASSAY, MODIFICATION

Applicant Diagnostic Reagents, Inc.

K number K920957

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LCM 1992-03-18

ABUSCREEN ONLINE FOR PHENCYCLIDINE

Applicant Roche Diagnostic Systems, Inc.

K number K920935

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LCM 1992-01-27

EMIT D.A.U. PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K915728

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LCM 1991-12-09

PHENCYCLIDINE EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K915179

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LCM 1991-11-07

IL TEST(TM) PHENCYCLIDINE

Applicant Instrumentation Laboratory CO

K number K913743

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LCM 1991-06-18

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

Applicant Immunotech Corp.

K number K911153

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LCM 1991-06-03

ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K911725

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LCM 1990-11-28

EMIT (R) II PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K904765

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LCM 1990-08-17

MILENIA(TM) PCP

Applicant Diagnostic Products Corp.

K number K902960

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LCM 1990-04-26

HYCOR ACCUPINCH PHENCYCLIDINE TEST

Applicant Hycor Biomedical, Inc.

K number K900921

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LCM 1990-04-25

TDX PHENCYCLIDINE II ASSAY

Applicant Abbott Laboratories

K number K900940

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LCM 1990-01-26

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)

Applicant Roche Diagnostic Systems, Inc.

K number K895906

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LCM 1989-08-25

ADX TM PHENCYCLIDINE

Applicant Abbott Laboratories

K number K890688

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LCM 1987-11-13

REVISED LABELING FOR PCP TEST KIT

Applicant Roche Diagnostic Systems, Inc.

K number K874267

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LCM 1987-10-15

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE

Applicant Diagnostic Products Corp.

K number K873756

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LCM 1985-11-05

TDX PHENCYCLIDINE

Applicant Abbott Laboratories

K number K854167

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LCM 1985-09-18

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS

Applicant American Dade

K number K853548

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LCM 1984-09-27

EMIT 700 PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K843509

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LCM 1984-03-22

EMIT ST SERUM PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K840199

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LCM 1984-03-19

EMIT ST URINE PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K840061

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LCM 1981-03-17

EMIT-ST SERUM PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K810601

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LCM 1981-02-02

EMIT-ST PHENCYCLIDINE ASSAY

Applicant Syva Co.

K number K810093

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LCM 1979-06-15

PHENCYCLIDINE URINE ASSAY

Applicant Syva Co.

K number K790401

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