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510(k) K910525

Device
MICROLINE SCREEN FOR METHAMPHETAMINE
Applicant
DRUG SCREENING SYSTEMS, INC.
510(k) number
K910525
Product code
DIT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-05
Date received
1991-02-07
Regulation
862.3100
Classification name
Thin Layer Chromatography, Amphetamine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH S CARPENTER
Address
603 Vpr Commerce Center P.O. Box 579 Blackwood NJ US 08012 08012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DIT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972577QUICK SCREEN ONE STEP AMPHETAMINE TESTPhamatech1997-08-20
K901276HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROLDiagnostic Products Corp.1990-04-26
K790805DRUG ABUSE DIPSTICKSTechnical Resources, Inc.1979-06-06

Legacy Summary#

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FDA Review#

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