FDA 510(k) Applications for Medical Device: Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA 510(k) Applications for Medical Device:
Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K983281	ABBOTT LABORATORIES	DEPT. 09VA LC-2	IRVING	TX	75038
K980812	AXIS BIOCHEMICALS, ASA	PO BOX 262069	SAN DIEGO	CA	92196
K000121	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K050487	BIOKIT S.A.	CAN MALE LLISSA D'AMUNT	BARCELONA		08186
K013128	DADE BEHRING, INC.	GLASGOW SITE	NEWARK	DE	19714-6101
K013359	DENKA SEIKEN'S	3-4-2 NIHONBASHI	TOKYO		103-0025
K993669	DIASORIN, INC.	9175 GUIFORD RD.	COLUMBIA	MD	21046
K001118	DIASORIN, INC.	4029 CHARIOT'S FLIGHT WAY	ELLICOTT CITY	MD	21042
K982708	DIASORIN, INC.	9175 GUIFORD RD.	COLUMBIA	MD	21046
K994110	DIASORIN/AMERICAN STANDARD COMPANIES	9175 GUILFORD RD., SUITE 100	COLUMBIA	MD	21046
K180074	Diazyme Laboratories, Inc.	12889 Gregg Court	Poway	CA	92130
K082488	GENERAL ATOMICS	12889 GREGG COURT	POWAY	CA	92064
K021660	KAMIYA BIOMEDICAL CO.	910 INDUSTRY DR.	SEATTLE	WA	98188-3412
K023853	KAMIYA BIOMEDICAL CO.	910 INDUSTRY DR.	SEATTLE	WA	98188-3412
K970302	PERIMMUNE, INC.	1330 PICCARD DR.	ROCKVILLE	MD	20850-4396
K122722	Roche Diagnostics	9115 HAGUE ROAD	INDIANAPOLIS	IN	46250-0416
K990595	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K013206	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46256
K013207	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46256
K211058	Sentinel CH. SpA	Via Robert Koch 2	Milan		20152
K123046	Siemens Healthcare Diagnostics Inc.	511 BENEDICT AVE.	TARRYTOWN	NY	10591
K063838	THERMO ELECTRON OY	RATASTIE 2	VANTAA		01620
K992665	TRINITY BIOTECH USA	P.O. BOX 1059	JAMESTOWN	NY	14702-1059
K981446	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001931	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001934	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001933	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001929	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001920	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001919	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001921	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237