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510(k) K010045

Device
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
510(k) number
K010045
Product code
LCM  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-29
Date received
2001-01-05
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NAISHU WANG
Address
12330 Stowe Dr. Poway CA US 92064 92064

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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