FDA 510(k) Applications for Medical Device: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA 510(k) Applications for Medical Device:
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K002376	BAYER CORP.	63 NORTH ST.	MEDFIELD	MA	02052-1688
K994221	BAYER CORP.	63 NORTH ST.	MEDFIELD	MA	02052-1688
K022288	BAYER CORP.	511 BENEDICT AVE.	TARRYTOWN	NY	10591-5097
K980376	BAYER CORP.	511 BENEDICT AVE.	TARRYTOWN	NY	10591-5097
K022177	BAYER DIAGNOSTICS CORP.	511 BENEDICT AVE.	TARRYTOWN	NY	10591-5097
K974816	BECKMAN INSTRUMENTS, INC.	1000 LAKE HAZELTINE DR.	CHASKA	MN	55318-1084
K964595	BEHRING DIAGNOSTICS, INC.	151 UNIVERSITY AVE.	WESTWOOD	MA	02090
K981634	BIOCIRCUITS CORP.	1324 CHESAPEAKE TERR.	SUNNYVALE	CA	94089
K010550	BIOMERIEUX, INC.	595 ANGLUM RD.	HAZELWOOD	MO	63042
K974189	BOEHRINGER MANNHEIM CORP.	4300 HACIENDA DR.	PLEASANTON	CA	94588-2722
K964351	BOEHRINGER MANNHEIM CORP.	2400 BISSO LN.	CONCORD	CA	94524-4117
K982948	BOEHRINGER MANNHEIM CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K982949	BOEHRINGER MANNHEIM CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K965085	BOEHRINGER MANNHEIM CORP.	9115 HAGUE RD.	INDIANAPOLIS	IN	46250-0457
K981839	CHIRON DIAGNOSTICS CORP.	63 NORTH ST.	MEDFIELD	MA	02052
K003963	DADE BEHRING, INC.	GLASGOW BUSINESS COMMUNITY;	NEWARK	DE	19714-6101
K031343	DADE BEHRING, INC.	BLDG. 500 MAIL BOX 514	NEWARK	DE	19714-6101
K973101	DADE CHEMISTRY SYSTEMS, INC.	GLASGOW SITE	NEWARK	DE	19714-6101
K974842	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K972095	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K972021	DIAGNOSTIC PRODUCTS CORP.	5700 WEST 96TH ST.	LOS ANGELES	CA	90045-5597
K973243	DIAGNOSTIC SYSTEMS LABORATORIES, INC.	445 MEDICAL CENTER BLVD.	WEBSTER	TX	77598
K973244	DIAGNOSTIC SYSTEMS LABORATORIES, INC.	445 MEDICAL CENTER BLVD.	WEBSTER	TX	77598
K124056	NANOEN TEK, INC.	1 JACK'S HILL RD. SUITE 1 (A&B)	OXFORD	CT	06478
K162378	NANOENTEK USA INC	5627 STONERIDGE DRIVE SUITE 304	PLEASANTON	CA	94588
K980716	NICHOLS INSTITUTE DIAGNOSTICS	33051 CALLE AVIADOR	SAN JUAN CAPISTRANO	CA	92675
K002313	ONCOGENE SCIENCE, INC.	80 ROGERS ST.	CAMBRIDGE	MA	02142
K002121	ONCOGENE SCIENCE, INC.	80 ROGERS ST.	CAMBRIDGE	MA	02142
K000566	Ortho-Clinical Diagnostics, Inc.	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K984289	Ortho-Clinical Diagnostics, Inc.	100 INDIGO CREEK DR.	ROCHESTER	NY	14626-5101
K003094	Qualigen, Inc.	2042 CORTE DEL NOGAL	CARLSBAD	CA	92009
K994419	QUALISYS DIAGNOSTICS, INC.	2042 CORTE DEL NOGAL	CARLSBAD	CA	92009
K990234	QUALISYS DIAGNOSTICS, INC.	16 TECHNOLOGY DR., SUITE 118	IRVINE	CA	92618