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510(k) K113751

Device
RANDOX COCAINE METABOLITE
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K113751
Product code
DIO  
Decision
Substantially Equivalent (SESE)
Decision date
2012-05-08
Date received
2011-12-21
Regulation
862.3250
Classification name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAULINE ARMSTRONG
Address
55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DIO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.2022-01-27
K211973DRI Cocaine Metabolite AssayMicrogenics Corporation2021-09-24
K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX2020-03-12
K181499DRI Cocaine Metabolite AssayMicrogenics Corporation2018-07-06
K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.2017-10-25
K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation2017-08-15
K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC2017-06-02
K152232Quest Diagnostics HairCheck-DT (Cocaine)Quest Diagnostics Incorporated2016-11-18
K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)Guangzhou Wondfo Biotech Co., Ltd.2016-06-27
K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test MarijuanaSafecare Biotech (Hangzhou) Co., Ltd.2016-03-18
K142129RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SETBiophor Diagnostics, Inc.2015-07-24
K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control SetImmunalysis Corporation2015-06-29
K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestW.H.P.M., Inc.2014-10-07
K141647HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)Healgen Scientific,, LLC2014-07-17
K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESOmega Laboratories, Inc.2013-11-13

Legacy Summary#

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FDA Review#

Decision Summary