FDA 510(k) Applications for Medical Device:
Test, Time, Prothrombin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K220282 | Abbott Laboratories |
400 College Road East | Princeton | NJ | 08540 |
| K110212 | ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE |
9975 Summers Ridge Road | San Diego | CA | 92121 |
| K052124 | AMERICAN DIAGNOSTICA, INC. |
500 WEST AVENUE | STAMFORD | CT | 06902 |
| K994006 | AVOCET MEDICAL, INC. |
100 GREAT OAKS BLVD. | SAN JOSE | CA | 95119 |
| K991286 | AVOCET MEDICAL, INC. |
100 GREAT OAKS BLVD. | SAN JOSE | CA | 95119 |
| K092987 | BIOSITE INCORPORATED |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K962571 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K955843 | CARDIOVASCULAR DIAGNOSTIC SERVICES |
5301 DEPARTURE DR. | RALEIGH | NC | 27604 |
| K954625 | CARDIOVASCULAR DIAGNOSTICS, INC. |
5301 DEPARTURE DR. | RALEIGH | NC | 27616 |
| K991065 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K093243 | COAGUSENSE, INC |
42840 CHRISTY ST SUITE 110 | FREMONT | CA | 94538 |
| K212779 | CoaguSense, Inc. |
48377 Fremont Blvd. Suite 113 | Fremont | CA | 94538 |
| K183255 | CoaguSense, Inc. |
48377 Fremont Blvd. Suite #113 | Fremont | CA | 94538 |
| K013155 | DADE BEHRING, INC. |
13251 NW 9TH TERRACE | MIAMI | FL | 33182 |
| K003870 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K974343 | DADE INTL., INC. |
2173 NW 99TH AVE. | MIAMI | FL | 33172 |
| K211485 | Diagnostica Stago SAS |
3 allΘe ThΘrΘsa | AsniΘres sur Seine | 92600 | |
| K020679 | HEMOSENSE, INC. |
600 VALLEY WAY | MILPITAS | CA | 95035 |
| K072727 | HEMOSENSE, INC. |
651 RIVER OAKS PARKWAY | SAN JOSE | CA | 95134 |
| K021923 | HEMOSENSE, INC. |
600 VALLEY WAY | MILPITAS | CA | 95035 |
| K020355 | I-STAT CORPORATION |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08540 |
| K251564 | iLine Microsystems S.L. |
Paseo Mikeletegi 69. | Donostia | 20006 | |
| K243543 | iLine Microsystems S.L. |
Paseo Mikeletegi 69. | Donostia | 20009 | |
| K201185 | iLine Microsystems S.L. |
Paseo Mikeletegi, 69 | San Sebastian-Donostia | 20009 | |
| K231711 | iLine Microsystems S.L. |
Paseo Mikeletegi, 69 | San Sebastian-Donostia | 20009 | |
| K180780 | iLine Microsystems S.L. |
Paseo Mikeletegi, 69. Planta 1. | Donostia-San Sebastian | 20009 | |
| K060931 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K122584 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K213426 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K012768 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K043184 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K070005 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K132722 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K981479 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K972866 | INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K961835 | INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. | EDISON | NJ | 08820 |
| K010599 | INTERNATIONAL TECHNIDYNE CORP. |
6 OLSEN AVE. | EDISON | NJ | 08820 |
| K022922 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K001699 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K961938 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K974566 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K994100 | PACIFIC HEMOSTASIS |
11515 VANSTORY DR. | HUNTERSVILLE | NC | 28078-8144 |
| K040296 | R2 DIAGNOSTICS, INC. |
412 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46601 |
| K170960 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K180684 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K071041 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K180693 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K093460 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K060978 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAP0LIS | IN | 46256 |
| K030845 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K092940 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K062925 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K072920 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K020831 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K021190 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K992492 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K151964 | SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K972796 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
| K230802 | Universal Biosensors Pty Ltd |
1 Corporate Avenue | Rowville | 3178 | |
| K020840 | VITAL SCIENTIFIC N.V. |
ONE GATEWAY CENTER SUITE 411 | NEWTON | MA | 02458 |
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