FDA 510(k) Applications for Medical Device:
Electrode, Ion Specific, Potassium
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K093318 |
ABBOTT LABORATORIES |
1920 HURD DRIVE
| IRVING |
TX |
75038 |
K993083 |
ABBOTT LABORATORIES |
DEPT. 09VA LC-2
| IRVING |
TX |
75038 |
K974784 |
AVL SCIENTIFIC CORP. |
33 MANSELL COURT
| ROSWELL |
GA |
30076-4807 |
K112412 |
BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD
| BREA |
CA |
92821 |
K042291 |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD.,W-104
| BREA |
CA |
92822-8000 |
K040750 |
CLINICAL ANALYSIS CORPORATION, INC. |
2100 QUAKER POINTE DRIVE
| QUAKERTOWN |
PA |
18951-2182 |
K010061 |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY;
| P.O. BOX 6101, NEWARK |
DE |
19714-6101 |
K970330 |
DADE INTL., INC. |
BUILDING 500, MAILBOX 514
| NEWARK |
DE |
19714-6101 |
K200544 |
Diamond Diagnostics Inc. |
333 Fiske Street
| Holliston |
MA |
01746 |
K121040 |
DIAMOND DIAGNOSTICS, INC. |
333 FISKE ST.
| HOLLISTON |
MA |
01746 |
K092849 |
EPOCAL, INC. |
2060 WALKLEY RD.
| OTTAWA, ONTARIO |
|
K1G-3P5 |
K121012 |
INPECO S.P.A. |
11 VIA G. DI VITTORIO
| SEGRATE, MILAN |
|
20090 |
K112995 |
INSTRUMENTATION LABORATORY CO. |
526 ROUTE 303
| ORANGEBURG |
NY |
10962 |
K961115 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR.
| ROCHESTER |
NY |
14650-0882 |
K112788 |
MEDICA CORP. |
5 OAK PARK DRIVE
| BEDFORD |
MA |
01730 |
K961326 |
MEDICA CORP. |
14 DEANGELO DR.
| BEDFORD |
MA |
01730 |
K220396 |
Medica corporation |
5 Oak Park Drive
| Bedford |
MA |
01730 |
K073157 |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR.
| ROCHESTER |
NY |
14626-5101 |
K083680 |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR.
| ROCHESTER |
NY |
14626-5101 |
K061730 |
OSMETECH, INC. |
235 HEMBREE PARK DRIVE
| ROSWELL |
GA |
30076 |
K112408 |
POLYMEDCO, INC. |
510 FURNACE DOCK RD.
| CORTLANDT MANOR |
NY |
10567 |
K092686 |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21
| BRONSHOJ |
|
DK-2700 |
K230890 |
Randox Laboratories Ltd. |
55 Diamond Road
| Crumlin |
|
BT29 4QY |
K052914 |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD.
| CRUMLIN, COUNTY ANTRIM |
|
BT29 4QY |
K060373 |
Roche Diagnostics |
9115 HAGUE ROAD
| INDIANAPOLIS |
IN |
46250-0416 |
K013373 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD.
| INDIANAPOLIS |
IN |
46250 |
K032311 |
ROCHE DIAGNOSTICS CORP. |
P.O. BOX 50457
| INDIANAPOLIS |
IN |
46250-0457 |
K042270 |
STAT CHEM, INC. |
619 NORTH POPLAR STREET
| ORANGE |
CA |
92868 |
K061107 |
THERMO ELECTRON OY |
RATASTIE 2
| VANTAA |
|
01620 |
K110520 |
TOKYO BOEKI MEDISYS INC. |
5105 FAIROAKS ROAD
| DURHAM |
NC |
27712 |
|
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