DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

Calibrator, Primary

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 C-reactive Protein Calibrator.

Pre-market Notification Details

• Device ID: K053104
• 510k Number: K053104
• Device Name: DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
• Classification: Calibrator, Primary
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY P.O. BOX 6101 BUILDING 500 Newark, DE 19714 -6101
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY P.O. BOX 6101 BUILDING 500 Newark, DE 19714 -6101
• Product Code: JIS
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-04
• Decision Date: 2005-12-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016011	K053104	000