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510(k) K950134

Device
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K950134
Product code
DLN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-21
Date received
1995-01-13
Regulation
862.3250
Classification name
Hemagglutination, Cocaine Metabolites (benzoylecgnonine)
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 DLN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924113ABUSCREEN ONLINE FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.1992-12-28
K792429HIM TEST COCAINETecknam, Inc.1979-12-07
K760401COCAINE KIT, TOXI-PAKJ.T. Baker Chemical Co.1976-08-26

Legacy Summary#

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FDA Review#

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