FDA 510(k) Applications for Medical Device: Calibrator, Primary

FDA 510(k) Applications for Medical Device:
Calibrator, Primary

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K010696	BECKMAN COULTER, INC.	200 SOUTH KRAEMER BLVD. W-110	BREA	CA	92822
K994325	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K994169	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K000331	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K994168	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K983640	BECKMAN COULTER, INC.	200 S. KRAEMER BLVD.,M/S W-104	BREA	CA	92822-8000
K053104	DADE BEHRING, INC.	GLASGOW BUSINESS COMMUNITY	NEWARK	DE	19714-6101
K060266	DADE BEHRING, INC.	P.O. BOX 6101 BUILDING 500	NEWARK,	DE	19714
K994114	DADE BEHRING, INC.	P.O. BOX 6101	NEWARK	DE	19714-6101
K032697	DADE BEHRING, INC.	GLASGOW BUSINESS COMMUNITY	NEWARK	DE	19714
K061251	DADE BEHRING, INC.	BLDG 500; M.S. 514	NEWARK	DE	19714-6101
K013126	DADE BEHRING, INC.	GLASGOW SITE	NEWARK	DE	19714-6101
K030546	DENKA SEIKEN CO., LTD.	KAGAMIDA FACILITY	GOSEN CITY, NIIGATA		959-1695
K032608	GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB	SCHOENHAUSER STRASSE 73C	BERLIN		13158
K030964	INSTRUMENTATION LABORATORY CO.	180 HARTWELL ROAD	BEDFORD	MA	01730
K022901	ORTHO-CLINICAL DIAGNOSTICS	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K994145	Ortho-Clinical Diagnostics, Inc.	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K032296	Ortho-Clinical Diagnostics, Inc.	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K964475	OXARC, INC.	716 SOUTH OREGON AVE.	PASCO	WA	99301
K970933	POINTE SCIENTIFIC, INC.	1025 JOHN A. PAPALAS DR.	LINCOLN PARK	MI	48146
K122126	RANDOX LABORATORIES LIMITED	34 DIAMOND ROAD	CRUMLIN ANTRIM		BT29 4QY
K022682	RANDOX LABORATORIES, LTD.	55 DIAMOND RD.	CRUMLIN, COUNTY ANTRIM		BT29 4QY
K011568	RANDOX LABORATORIES, LTD.	55 DIAMOND RD.	CRUMLIN, COUNTY ANTRIM		BT29 4QY
K003969	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K002353	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K002760	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K003941	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K001906	ROCHE DIAGNOSTICS CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K012878	THERMO DMA, INC.	845 AVE. G EAST	ARLINGTON	TX	76011
K001004	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K030320	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K993219	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K963847	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001005	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237
K001002	WAKO CHEMICALS, USA, INC.	1600 BELLWOOD ROAD	RICHMOND	VA	23237