FDA 510(k) Applications for Medical Device:
Instrument, Coagulation, Automated

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K904297 AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD.
PARSIPPANY NJ 07054
K942117 AMERICAN BIOPRODUCTS CO. 5 CENTURY DR.
PARSIPPANY NJ 07054
K961579 AMERICAN BIOPRODUCTS CO. 5 CENTURY DR.
PARSIPPANY NJ 07054
K943153 BIO/DATA CORP. 155 CENTENNIAL PLAZA
HORSHAM PA 19044
K001891 BIO/DATA CORP. 155 GIBRALTAR RD.
HORSHAM PA 19044-0347
K931992 BIOMERIEUX VITEK, INC. 595 ANGLUM DR.
HAZELWOOD MO 63042 2395
K933092 CARDIOVASCULAR DIAGNOSTIC SERVICES 2810 MERIDIAN PKWY.
DURHAM NC 27713
K981206 CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR.
RALEIGH NC 27616
K031377 DADE BEHRING, INC. 500 GBC DR.
NEWARK DE 19702
K020979 DADE BEHRING, INC. P.O. BOX 6101
NEWARK DE 19714
K993299 DADE BEHRING, INC. 1851 DELAWARE PKWY.
MIAMI FL 33125
K001645 DADE BEHRING, INC. 7739 NW 48 ST.
MIAMI FL 33166
K992423 DADE BEHRING, INC. 1851 DELAWARE PKWY.
MIAMI FL 33125
K992763 DADE BEHRING, INC. 1851 DELAWARE PKWY.
MIAMI FL 33125
K992321 DADE BEHRING, INC. 1851 DELAWARE PKWY.
MIAMI FL 33125
K993174 DADE BEHRING, INC. 1851 DELAWARE PKWY.
MIAMI FL 33125
K001145 DADE BEHRING, INC. 7739 NW 48 ST.
MIAMI FL 33166
K964139 DADE INTL., INC. 9750 N.W. 25TH ST.
MIAMI FL 33172
K023362 FISHER DIAGNOSTICS 8365 VALLEY PIKE
MIDDLETOWN VA 22645-0307
K813564 GENERAL DIAGNOSTICS
K904204 HAEMOSCOPE CORP. 5836 LINCOLN AVE.
MORTON GROVE IL 60053
K954437 HAEMOSCOPE CORP. 7855 GROSS POINT RD.
SKOKIE IL 60077
K895844 HAEMOSCOPE CORP. 5836 LINCOLN AVE.
MORTON GROVE IL 60053
K921363 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K914946 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K901380 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K931956 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K921465 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K961991 INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE.
LEXINGTON MA 02173
K063679 INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD
BEDFORD MA 01730
K160276 INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD
BEDFORD MA 01730-2441
K073377 INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD
BEDFORD MA 01730
K091980 INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD
BEDFORD MA 01730
K150877 Instrumentation Laboratory Co. 180 Hartwell Road
Bedford MA 01730
K033414 INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD
BEDFORD MA 01730
K924098 INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE.
LEXINGTON MA 02173
K951072 INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST.
EDISON NJ 08820
K894052 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE.
PLEASANTVILLE NY 10570
K944227 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE.
PLEASANTVILLE NY 10570
K931206 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE.
PLEASANTVILLE NY 10570
K962664 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE.
PLEASANTVILLE NY 10570
K884863 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE.
PLEASANTVILLE NY 10570
K991101 ORGANON TEKNIKA CORP. 100 AKZO AVE.
DURHAM NC 27712
K962857 ORGANON TEKNIKA CORP. 100 AKZO AVE.
DURHAM NC 27712
K881281 ORGANON TEKNIKA CORP. 800 CAPITOLA DR.
DURHAM NC 27713
K901120 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869 0606
K885035 ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202
RARITAN NJ 08869 0606




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