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510(k) K011161

Device
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
Applicant
SYVA CO., DADE BEHRING, INC.
510(k) number
K011161
Product code
LCM  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-15
Date received
2001-04-16
Regulation
510(k) Premarket Notification
Classification name
Enzyme Immunoassay, Phencyclidine
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Toxicology
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUSAN COLLINS
Address
3403 Yerba Buena Rd. San Jose CA US 95135 95135

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
K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2021-04-20
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

Legacy Summary#

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FDA Review#

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