DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B

Colorimetric Method, Lipoproteins

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Ahdl Flex Reagent Cartridge, Model: Df48b.

Pre-market Notification Details

• Device ID: K073072
• 510k Number: K073072
• Device Name: DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
• Classification: Colorimetric Method, Lipoproteins
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Contact: Pamela A Jurga
• Correspondent: Pamela A Jurga; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Product Code: JHM
• CFR Regulation Number: 862.1475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-31
• Decision Date: 2008-02-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768022029	K073072	000