Urine Cocaine Metabolite Screen Flex(Tm) Reagent Catridge

FDA 510(k) K950134 · E.I. Dupont DE Nemours & Co., Inc.

Substantially Equivalent

510(k) numberK950134

Submission

Device name
Urine Cocaine Metabolite Screen Flex(Tm) Reagent Catridge
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US
Received
January 13, 1995
Decision date
March 21, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DLN – Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Specialty
Clinical Toxicology

Other 510(k)s with product code DLN

510(k)DeviceApplicantDecision
K924113Abuscreen Online for Cocaine MetaboliteDLN · Traditional Roche Diagnostic Systems, Inc.12/28/1992SE
K792429Him Test CocaineDLN · Traditional Tecknam, Inc.12/07/1979SE
K760401Cocaine Kit, Toxi-PakDLN · Traditional J.T. Baker Chemical Co.08/26/1976SE

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Questions and answers

When was Urine Cocaine Metabolite Screen Flex(Tm) Reagent Catridge cleared by the FDA?

Urine Cocaine Metabolite Screen Flex(Tm) Reagent Catridge (K950134) received a 510(k) decision of Substantially Equivalent on March 21, 1995, 67 days after the submission was received.

What is the product code of K950134?

The FDA product code is DLN – Hemagglutination, Cocaine Metabolites (Benzoylecgnonine), a Class II (moderate risk) device regulated under 21 CFR 862.3250.