DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE

Cardiac C-reactive Protein, Antigen, Antiserum, And Control

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Cardiophase High Sensitivity Crp Flex Reagent Cartridge.

Pre-market Notification Details

• Device ID: K053109
• 510k Number: K053109
• Device Name: DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
• Classification: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101
• Product Code: NQD
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-04
• Decision Date: 2005-12-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016028	K053109	000