FDA 510(k) Applications for Medical Device:
Electrode, Ion-Specific, Chloride
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K991870 |
A.P. TOTAL CARE, INC. |
70 HAWLEY AVE,
| BRIDGEPORT |
CT |
|
| K980367 |
ABBOTT LABORATORIES |
1920 HURD DRIVE
| IRVING |
TX |
75038 |
| K170320 |
Abbott Laboratories |
Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road
| Abbott Park |
IL |
60064 |
| K963734 |
ALKO DIAGNOSTIC CORP. |
333 FISKE ST.
| HOLLISTON |
MA |
01746 |
| K972004 |
ALKO DIAGNOSTIC CORP. |
333 FISKE ST.
| HOLLISTON |
MA |
01746 |
| K981270 |
DIAMETRICS MEDICAL, INC. |
2658 PATTON RD.
| SAINT PAUL |
MN |
55113 |
| K980757 |
INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE.
| LEXINGTON |
MA |
02173 |
| K963992 |
MEDICA CORP. |
14 DEANGELO DR.
| BEDFORD |
MA |
01730 |
| K000926 |
MEDICA CORP. |
14 DEANGELO DR.
| BEDFORD |
MA |
01730 |
| K162020 |
Ortho Clinical Diagnostics |
100 Indigo Creek Drive
| Rochester |
NY |
14626 |
| K082099 |
Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR.
| ROCHESTER |
NY |
14626-5101 |
| K182072 |
Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive
| Rochester |
NY |
14626 |
| K052027 |
OSMETECH, INC. |
235 HEMBREE PARK DRIVE
| ROSWELL |
GA |
30076 |
| K020148 |
PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE
| NATICK |
MA |
01760 |
| K013451 |
PHOENIX DIAGNOSTICS, INC. |
8 TECH CIRCLE
| NATICK |
MA |
01760 |
| K060108 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD.
| INDIANAPOLIS |
IN |
46250 |
| K973742 |
SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY
| CARLSBAD |
CA |
92011 |
| K962479 |
SYNERMED, INC. |
1688 50TH AVENUE,
| QUEBEC, CANADA |
|
H8T 2V5 |
| K070531 |
Thermo Fisher Scientific |
171 INDUSTRY DRIVE
| PITTSBURGH |
PA |
15275 |
| K003668 |
WALLAC OY |
MUSTIONKATU 6
| TURKU |
|
20750 |
| K070889 |
WALLAC OY |
MUSTIONKATU 6
| TURKU |
|
20750 |
| K993697 |
WALLAC OY |
MUSTIONKATU 6
| TURKU |
|
20750 |
| K003664 |
WALLAC OY |
MUSTIONKATU 6
| TURKU |
|
20750 |
|
|