FDA 510(k) Applications for Medical Device: Fluorometric Method, Cpk Or Isoenzymes

FDA 510(k) Applications for Medical Device:
Fluorometric Method, Cpk Or Isoenzymes

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K980012	AC BIOCHEMICALS, INC.	17955 SKY PARK CIRCLE, SUITE J	IRVINE	CA	92614
K000716	BECKMAN COULTER, INC.	1000 LAKE HAZELTINE DR.	CHASKA	MN	55318-1084
K994439	BECKMAN COULTER, INC.	1000 LAKE HAZELTINE DR.	CHASKA	MN	55318-1084
K030012	BECKMAN COULTER, INC.	1000 LAKE HAZELTINE DR.	CHASKA	MN	55318-1084
K962549	BIOMERIEUX VITEK, INC.	1022 HINGHAM ST.	ROCKLAND	MA	02370
K973126	BIOSITE INCORPORATED	11030 ROSELLE ST.	SAN DIEGO	CA	92121
K984067	DADE BEHRING, INC.	GLASGOW SITE	NEWARK	DE	19714-6101
K051650	DADE BEHRING, INC.	GLASGOW BUSINESS COMMUNITY	NEWARK	DE	19714-6101
K981099	DADE BEHRING, INC.	PO BOX 6101	NEWARK	DE	19714-6101
K972782	DADE INTL., INC.	P.O. BOX 6101	NEWARK	DE	19714
K034055	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K004002	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K022118	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K991797	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K013118	FIRST MEDICAL, INC.	3722 AVE. SAUSALITO	IRVINE	CA	92606
K041596	FISHER DIAGNOSTICS	8365 VALLEY PIKE, PO BX 307	MIDDLETOWN	VA	22645
K081360	MITSUBISHI KAGAKU IATRON	701 FIFTH AVENUE	SEATTLE	WA	98104
K212648	Ortho Clinical Diagnostics	Felindre Meadows	Pencoed		CF35 5PZ
K993068	ORTHO-CLINICAL DIAGNOSTICS	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K120326	RADIOMETER MEDICAL APS	AKANDEVEJ 21	BRONSHOJ		DK-2700
K163462	Radiometer Medical ApS	Aakandevej 21	Broenshoej		2700
K033747	RESPONSE BIOMEDICAL CORP.	8081 LOUGHEED HWY.	BURNABY, BRITISH COLUMBIA		V5A 1W9