MDRWeb Medical Device Register On-line from Canon Communications, LLC

Search for:

510(k) Premarket Notification Database

Device Classification Name:	COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Regulation Number:	870.1425 [See Other Products with this regulation number]
510(k) Number:	K031377
Device Name:	SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Applicant:	DADE BEHRING, INC. 500 GBC DR. NEWARK, DE 19702
Contact:	RADAMES RIESGO
Product Code:	DQK [See Other Manufacturers that make this Product]
Date Received:	05-01-2003
Decision Date:	09-08-2003
Decision:	SE
Advisory Committee:	HE
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

Canon Communications medical device and pharmaceutical media network includes:
Qmed Medical Device & Diagnostic Industry Medical Product & Manufacturing News European Medical Device Technology China Medical Device Manufacturer In Vitro Diagnostic Technology	Med Ad News R&D Directions PharmaLive.com Pharmalot.com eKnowledgebase Pharmaceutical & Medical Packaging News Packaging Digest