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 |
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 |
K020840 |
VITAL SCIENTIFIC N.V. |
ONE GATEWAY CENTER SUITE 411
| NEWTON |
MA |
02458 |
|
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