FDA 510(k) Applications for Medical Device:
Diazo Colorimetry, Bilirubin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991866 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K223324 | Abbott Ireland Diagnostics Division |
Lisnarnuck | Longford | ||
| K121985 | ABBOTT LABORATORIES |
1921 HURD DRIVE | IRVING | TX | 75038 |
| K981943 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K022180 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K981222 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K991175 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K981336 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K983133 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K022339 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K150510 | ABBOTT LABORATORIES |
1921 HURD DRIVE | IRVING | TX | 75013 |
| K060574 | ABBOTT LABORATORIES |
1921 HURD DRIVE | IRVING | TX | 75038 |
| K051432 | ARKRAY, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K972382 | ARROWS CO., LTD. |
2-7-50 NISHIMIYAHARA YODOGA-KU | OSAKA | ||
| K993867 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K981883 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K993771 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K981588 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K972073 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K040631 | CLINICAL DATA, INC. |
1075 WEST LAMBERT ROAD | BREA | CA | 92821-2944 |
| K981276 | CRESTAT DIAGNOSTICS, INC. |
910 INDUSTRY DR. | SEATTLE | WA | 98056 |
| K981289 | CRESTAT DIAGNOSTICS, INC. |
910 INDUSTRY DR. | SEATTLE | WA | 98056 |
| K060628 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K061839 | DADE BEHRING, INC. |
P.O. BOX 6101 MS 514 | NEWARK | DE | 19714-6101 |
| K061719 | DADE BEHRING, INC. |
P.O. BOX 6101 MS 514 | NEWARK | DE | 19714-6101 |
| K955940 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K981609 | DIAGNOSTIC CHEMICALS LTD. |
16 FIRST ST. | CHARLOTTETOWN, P.E.I. | C1E1B0 | |
| K023330 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K955880 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K974874 | DIAGNOSTIC CHEMICALS, LTD. (USA) |
16 FIRST ST. | CHARLOTTESTOWN,PEI,CANADA | C1E 1B0 | |
| K030003 | ELAN DIAGNOSTICS |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K030014 | ELAN DIAGNOSTICS |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K110780 | ELITECH GROUP |
21720 23RD DR S.E., SUITE 150 | BOTHELL | WA | 98021 |
| K171401 | ELITechGroup |
Zone Industrielle | Sees | 61500 | |
| K082210 | GENZYME DIAGNOSTICS P.E.I. INC. |
70 WATTS AVENUE | CHARLOTTETOWN, PRIN ED ISLAND | C1E 2B9 | |
| K131217 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
630 CLYDE CT. | MOUNTAIN VIEW | CA | 94043 |
| K060325 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER, HERAULT | 34184 | |
| K093623 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL AVE. | BEDFORD | MA | 01730 |
| K011972 | INTERSECT SYSTEMS, INC. |
P.O. BOX 2219 | LONGVIEW | WA | 98632 |
| K003892 | INTERSECT SYSTEMS, INC. |
P.O. BOX 2219 | LONGVIEW | WA | 98632 |
| K003693 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K003829 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K091991 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K080810 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K123802 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K061830 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K080435 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
3500 CORPORATE PKWAY | CENTER VALLEY | PA | 18034 |
| K190807 | Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K040391 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K111143 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K050869 | RADIOMETER MEDICAL APS |
1455 PENNSYLVANIA AVENUE N.W. | WASHINGTON | DC | 20004 |
| K063744 | ROCHDIAG |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K131544 | Roche Diagnostics |
9115 SOUTH HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K081193 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K123965 | Roche Diagnostics |
9115 SOUTH HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K063543 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K981632 | ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K223078 | Siemens Healthcare Diagnostics Inc. |
500 GBC Drive, | Newark | DE | 19714 |
| K222104 | Siemens Healthcare Diagnostics Inc. |
500 GBC Drive | Newark | DE | 19714 |
| K983304 | SYNERMED INTL., INC. |
1688 50TH AVE. | LACHINE, QUEBEC | H8T 2V5 | |
| K963939 | SYNERMED, INC. |
1688 50TH AVENUE, | QUEBEC, CANADA | H8T 2V5 | |
| K973109 | SYNERMED, INC. |
1688 50TH AVENUE, | QUEBEC, CANADA | H8T 2V5 | |
| K972716 | SYNERMED, INC. |
1688 50TH AVENUE, | QUEBEC, CANADA | H8T 2V5 | |
| K970986 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K022962 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 | |
| K024116 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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