URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# Df92a.

Pre-market Notification Details

• Device ID: K033713
• 510k Number: K033713
• Device Name: URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714
• Product Code: DIO
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-26
• Decision Date: 2004-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005824	K033713	000