DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

Albumin, Antigen, Antiserum, Control

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Microalbumin (malb) Flex Reagent Cartridge Method, Calibrator, Models Df114, Dc114.

Pre-market Notification Details

• Device ID: K033525
• 510k Number: K033525
• Device Name: DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
• Classification: Albumin, Antigen, Antiserum, Control
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Contact: Richard M Vaught
• Correspondent: Richard M Vaught; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Product Code: DCF
• CFR Regulation Number: 866.5040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-07
• Decision Date: 2004-01-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005312	K033525	000
00842768004896	K033525	000