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LCM — Enzyme Immunoassay, Phencyclidine Class U

FDA Device Classification

Classification Details

Product Code
LCM
Device Class
Class U
Regulation Number
Submission Type
Review Panel
TX
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212952psychemedics corporationPsychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairApril 18, 2022
K203489immunalysis corporationSEFRIA PCP Oral Fluid Enzyme ImmunoassayApril 20, 2021
K181135immunalysis corporationImmunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayJanuary 24, 2019
K163220siemens healthcare diagnosticsAtellica CH Phencyclidine (Pcp)April 6, 2017
K152176immunalysis corporationImmunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsSeptember 4, 2015
K142044guangzhou wondfo biotech coCR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINEAugust 25, 2014
K131181omega laboratoriesOMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEJune 25, 2013
K122703biophor diagnosticsRAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPApril 25, 2013
K111928psychemedicsPSYCHEMEDICS PHENCYCLIDINE EIAMay 1, 2012
K101746microgenicsTHERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYApril 8, 2011
K093989roche diagnosticsORAL FLUID PHENCYCLIDINEJanuary 25, 2011
K101059omega laboratoriesOMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINEJuly 12, 2010
K080431quantrx biomedical corporationRAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054January 8, 2009
K062094ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PNovember 22, 2006
K060353acro biotechACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000May 3, 2006
K042726quest diagnosticsQUEST DIAGNOSTICS HAIRCHECK-DT (PCPJuly 28, 2005
K043071randox laboratoriesRANDOX PHENCYCLIDINE ASSAYJanuary 27, 2005
K043305roche diagnosticsONLINE DAT PHENCYCLIDINE PLUSJanuary 10, 2005
K041578phamatechQUICKSCREEN, MODELS 9177X AND 9178XSeptember 10, 2004
K023109amedica biotechAMEDICA DRUG SCREEN PHENCYCLIDINE TESTDecember 16, 2002