FDA 510(k) Applications for Medical Device: Enzymatic Method, Ammonia

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K981467	ABBOTT LABORATORIES	1920 HURD DR.	IRVING	TX	75038
K981920	ABBOTT LABORATORIES	DEPT. 09VA LC-2	IRVING	TX	75038
K023841	BAYER DIAGNOSTICS CORP.	511 BENEDICT AVE.	TARRYTOWN	NY	10591-5097
K021151	BAYER DIAGNOSTICS CORP.	511 BENEDICT AVE.	TARRYTOWN	NY	10591-5097
K984402	BECKMAN COULTER, INC.	200 SOUTH KRAEMER BLVD. W-110	BREA	CA	92822
K003196	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K062316	DADE BEHRING, INC.	GLASGOW BUSINESS COMMUNITY;	P.O. BOX 6101, NEWARK	DE	19714-6101
K964565	DADE INTL., INC.	9750 N.W. 25TH ST.	MIAMI	FL	33172
K033921	DIAGNOSTIC CHEMICALS LTD.	16 MCCARVILLE ST.	CHARLOTTETOWN		C1E 2A6
K001285	DIAGNOSTIC CHEMICALS LTD.	16 MCCARVILLE ST.	CHARLOTTETOWN		C1E 2A6
K030873	RANDOX LABORATORIES, LTD.	55 DIAMOND RD.	CRUMLIN, COUNTY ANTRIM		BT29 4QY
K183517	Roche Diagnostics Operations (RDO)	9115 Hague Road	Indianapolis	IN	46250
K051114	SENTINEL CH. SRL	5 VIA PRINCIPE EUGENIO	MILANO		20155
K123320	SIEMENS HEALTHCARE DIAGNOSTICS	MS 514, PO BOX 6101	NEWARK	DE	19714-6101
K123677	SIEMENS HEALTHCARE DIAGNOSTICS	500 GBC DRIVE M/S 514	NEWARK	DE	19702
K974620	TRACE AMERICA, INC.	7260 NORTH WEST 58TH ST.	MIAMI	FL	33166