FDA.reportPublic FDA data

510(k) K203489

Device
SEFRIA PCP Oral Fluid Enzyme Immunoassay
Applicant
Immunalysis Corporation
510(k) number
K203489
Product code
LCM
Decision
Substantially Equivalent (SESE)
Decision date
2021-04-20
Date received
2020-11-27
Classification name
Enzyme Immunoassay, Phencyclidine
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wenying (Jessica) Zhu
Address
829 Towne Center Dr. Pomona CA US 91767 91767

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LCM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation2022-04-18
K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2019-01-24
K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.2017-04-06
K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation2015-09-04
K142044CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINEGuangzhou Wondfo Biotech Co., Ltd.2014-08-25
K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.2013-06-25
K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, Inc.2013-04-25
K111928PSYCHEMEDICS PHENCYCLIDINE EIAPsychemedics Corp.2012-05-01
K101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYMicrogenics Corp.2011-04-08
K093989ORAL FLUID PHENCYCLIDINERoche Diagnostics2011-01-25
K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINEOmega Laboratories, Inc.2010-07-12
K080431RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054Quantrx Biomedical Corporation2009-01-08
K062094VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & VOrtho-Clinical Diagnostics, Inc.2006-11-22
K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000Acro Biotech, LLC2006-05-03
K042726QUEST DIAGNOSTICS HAIRCHECK-DT (PCPQuest Diagnostics, Inc.2005-07-28