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510(k) K201228

Device
Psychemedics Homogeneous Enzyme Immunoassay For Cocaine In Hair
Applicant
Psychemedics Corporation
510(k) number
K201228
Product code
JXO  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-25
Date received
2020-05-07
Regulation
862.3250
Classification name
Enzyme Immunoassay, Cocaine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neil Stowe
Address
5832 Uplander Way Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111925PSYCHEMEDICS COCAINE EIAPsychemedics Corp.2012-05-01
K923314AUTOMATES COMA PLUS COCAINE METABOLITE ASSAYSerex, Inc.1992-08-24
K921140STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIASolarcare Technologies Corp,Inc.1992-08-20
K915785STC DIAGNOSTICS BENZOYLECGONINE EIASolarcare Technologies Corp,Inc.1992-03-11
K913737IL TEST(TM) COCAINEInstrumentation Laboratory CO1991-12-03

Legacy Summary#

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FDA Review#

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