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510(k) K950182

Device
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K950182
Product code
DIW  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-21
Date received
1995-01-17
Regulation
862.3620
Classification name
Hemagglutination Inhibition, Methadone
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROLYN K GEORGE
Address
P.O. Box 80022 Barley Mill Plz., P22-1170 Wilmington DE US 19880 19880

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930845ROCHE ABUSCREEN ONTRAK FOR METHADONERoche Diagnostic Systems, Inc.1993-04-20
K801509HI-M-TEST FOR METHADONE TEST #2Technam, Inc.1980-07-14
K760075KIT, METHADONE (TOXI-PAK IMMUNO HI)J.T. Baker Chemical Co.1976-07-20

Legacy Summary#

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FDA Review#

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