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

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510(k) Premarket Notification Database

Device Classification Name:	COUNTER, CELL, DIFFERENTIAL CLASSIFIER, AUTOMATED
Regulation Number:	864.5220 [See Other Products with this regulation number]
510(k) Number:	K032524
Device Name:	ADVIA 60 HEMATOLOGY ANALYZER
Applicant:	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591
Contact:	KENNETH T EDDS
Product Code:	GKZ [See Other Manufacturers that make this Product]
Date Received:	08-15-2003
Decision Date:	09-08-2003
Decision:	SE
Advisory Committee:	HE
Statement/Summary/Purged Status:	Summary
Type:	Special
Review by Third Party:	N
Expedited Review:	N

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