SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

Instrument, Coagulation, Automated

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Sysmex Automated Coagulation Analyzer Ca500 Series (ca-510, -520, -530, -540. -550, And -560.

Pre-market Notification Details

• Device ID: K031377
• 510k Number: K031377
• Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
• Classification: Instrument, Coagulation, Automated
• Applicant: DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702
• Contact: Radames Riesgo
• Correspondent: Radames Riesgo; DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702
• Product Code: GKP
• CFR Regulation Number: 864.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-01
• Decision Date: 2003-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04987562425716	K031377	000