Atlas FDA

LCM

88 FDA 510(k) clearances · Product code

71 daysmedian time to decision
233 days90th percentile
88clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Medical specialty
Unknown
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RecordFirmDate
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (K212952)Psychemedics Corporation2022-04-18
SEFRIA PCP Oral Fluid Enzyme Immunoassay (K203489)Immunalysis Corporation2021-04-20
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (K181135)Immunalysis Corporation2019-01-24
Atellica CH Phencyclidine (Pcp) (K163220)Siemens Healthcare Diagnostics, Inc.2017-04-06
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176)Immunalysis Corporation2015-09-04
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (K142044)Guangzhou Wondfo Biotech Co., Ltd.2014-08-25
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (K131181)Omega Laboratories, Inc.2013-06-25
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR (K122703)Biophor Diagnostics, Inc.2013-04-25
PSYCHEMEDICS PHENCYCLIDINE EIA (K111928)Psychemedics Corp.2012-05-01
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (K101746)Microgenics Corp.2011-04-08
ORAL FLUID PHENCYCLIDINE (K093989)Roche Diagnostics2011-01-25
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (K101059)Omega Laboratories, Inc.2010-07-12
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 (K080431)Quantrx Biomedical Corporation2009-01-08
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (K062094)Ortho-Clinical Diagnostics, Inc.2006-11-22
ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 (K060353)Acro Biotech, LLC2006-05-03
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP (K042726)Quest Diagnostics, Inc.2005-07-28
RANDOX PHENCYCLIDINE ASSAY (K043071)Randox Laboratories, Ltd.2005-01-27
ONLINE DAT PHENCYCLIDINE PLUS (K043305)Roche Diagnostics Corp.2005-01-10
QUICKSCREEN, MODELS 9177X AND 9178X (K041578)Phamatech2004-09-10
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (K023109)Amedica Biotech, Inc.2002-12-16
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 (K020254)Lin-Zhi International, Inc.2002-05-10
PHENCYCLIDINE (K013096)Abbott Laboratories2002-03-13
AMEDITECH IMMUTEST DRUG SCREEN PCP (K012582)Ameditech, Inc.2001-11-30
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE (K011730)ACON Laboratories, Inc.2001-08-09
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (K012107)Pan Probe Biotech, Inc.2001-07-20
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST (K010045)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST (K010047)Alfa Scientific Designs, Inc.2001-05-29
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 (K011161)Syva Co., Dade Behring, Inc.2001-05-15
AT HOME DRUG TEST, MODEL 9133 T (K010651)Phamatech2001-03-30
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D (K002272)Branan Medical Corp.2000-11-22
MODIFICATION TO PROFILE -II (K002776)Medtox Diagnostics, Inc.2000-09-28
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (K000399)OraSure Technologies, Inc.2000-05-15
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST (K000402)Drug Detection Devices, Ltd.2000-04-18
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A (K000462)Dade Behring, Inc.2000-04-06
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (K994020)Roche Diagnostics Corp.2000-01-27
ONTRAK TESTCUP 5, CAT. 07 6481 7 (K994030)Roche Diagnostics Corp.2000-01-27
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 (K994017)Roche Diagnostics Corp.2000-01-27
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (K993983)Syva Co.2000-01-27
AT HOME DRUG TEST, MODEL 9133 (K994236)Phamatech1999-12-30
BIONIKE AQ PHENCYCLIDINE (PCP) TEST (K993945)Bionike Laboratories, Inc.1999-12-07
REDI-TEST PCP (K991698)Redwood Biotech, Inc.1999-08-25
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (K991505)Microdiagnostics, Inc.1999-08-05
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE (K983790)Sun Biomedical Laboratories, Inc.1999-03-01
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (K981363)Tcpi, Inc.1998-12-22
AUTO-LYTE PCP EIA, MODEL #1254U (K982801)OraSure Technologies, Inc.1998-11-04
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST (K981292)Syntron Bioresearch, Inc.1998-05-26
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (K981019)Syntron Bioresearch, Inc.1998-05-07
QUICKSCREEN ONE STEP PCP SCREENING TEST (K974582)Phamatech1998-02-04
MODIFIED CEDIA DAU PCP ASSAY (K972963)Boehringer Mannheim Corp.1997-09-22
ONTRAK TESTCUP 5 (MODIFICATION) (K964355)Roche Diagnostic Systems, Inc.1996-12-13
VERDICT PCP (K963692)Editek, Inc.1996-12-10
EZ-SCREEN PROFILE (K963233)Editek, Inc.1996-10-31
ACCUSIGN, BIOSIGN PCP (K961266)Princeton BioMeditech Corp.1996-05-31
AXSYM PHENCYCLIDINE II (K953534)Abbott Laboratories1995-10-26
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE (K950183)E.I. Dupont DE Nemours & Co., Inc.1995-03-20
EMIT IIC PHENCYCLIDINE ASSAY (K935191)Syva Co.1995-02-22
CEDIA(R) DAU PCP ASSAY (K946059)Microgenics Corp.1995-01-17
CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM (K944605)Beckman-Diagnostic Systems Group1994-12-07
EZ-SCREEN:PCP (K943711)Editek, Inc.1994-09-09
USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 (K935629)U.S. Drug Testing, Inc.1994-04-12
CEDIA(R) DAU PCP ASSAY (K935650)Microgenics Corp.1994-04-05
PHENCYCLIDINE EIA ASSAY (K935320)Diagnostic Reagents, Inc.1993-12-29
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY (K924751)Solarcare Technologies Corp,Inc.1992-12-11
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA (K924462)Solarcare Technologies Corp,Inc.1992-11-02
MICROLINE SCREEN FOR PHENCYCLIDINE (K921651)Drug Screening Systems, Inc.1992-07-08
ABUSCREEN ONLINE FOR PHENCYCLIDINE (K920935)Roche Diagnostic Systems, Inc.1992-03-18
PHENCYCLIDINE EIA ASSAY, MODIFICATION (K920957)Diagnostic Reagents, Inc.1992-03-18
EMIT D.A.U. PHENCYCLIDINE ASSAY (K915728)Syva Co.1992-01-27
PHENCYCLIDINE EIA ASSAY (K915179)Diagnostic Reagents, Inc.1991-12-09
IL TEST(TM) PHENCYCLIDINE (K913743)Instrumentation Laboratory CO1991-11-07
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (K911153)Immunotech Corp.1991-06-18
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD (K911725)E.I. Dupont DE Nemours & Co., Inc.1991-06-03
EMIT (R) II PHENCYCLIDINE ASSAY (K904765)Syva Co.1990-11-28
MILENIA(TM) PCP (K902960)Diagnostic Products Corp.1990-08-17
HYCOR ACCUPINCH PHENCYCLIDINE TEST (K900921)Hycor Biomedical, Inc.1990-04-26
TDX PHENCYCLIDINE II ASSAY (K900940)Abbott Laboratories1990-04-25
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) (K895906)Roche Diagnostic Systems, Inc.1990-01-26
ADX TM PHENCYCLIDINE (K890688)Abbott Laboratories1989-08-25
REVISED LABELING FOR PCP TEST KIT (K874267)Roche Diagnostic Systems, Inc.1987-11-13
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE (K873756)Diagnostic Products Corp.1987-10-15
TDX PHENCYCLIDINE (K854167)Abbott Laboratories1985-11-05
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS (K853548)American Dade1985-09-18
EMIT 700 PHENCYCLIDINE ASSAY (K843509)Syva Co.1984-09-27
EMIT ST SERUM PHENCYCLIDINE ASSAY (K840199)Syva Co.1984-03-22
EMIT ST URINE PHENCYCLIDINE ASSAY (K840061)Syva Co.1984-03-19
EMIT-ST SERUM PHENCYCLIDINE ASSAY (K810601)Syva Co.1981-03-17
EMIT-ST PHENCYCLIDINE ASSAY (K810093)Syva Co.1981-02-02
PHENCYCLIDINE URINE ASSAY (K790401)Syva Co.1979-06-15

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