FDA 510(k) Applications for Medical Device:
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K062028 |
CELERA DIAGNOSTICS |
1401 HARBOR BAY PKWY.
| ALAMEDA |
CA |
94502 |
K051435 |
CLINICAL MICRO SENSORS |
757 SOUTH RAYMOND AVENUE
| PASADENA |
CA |
91105 |
K060543 |
CLINICAL MICRO SENSORS, INC. |
757 SOUTH RAYMOND AVE.
| PASADENA |
CA |
91105 |
K083845 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE.
| TORONTO, ONTARIO |
|
M5G 1Y8 |
K163347 |
Luminex Molecular Diagnostics, Inc. |
439 University Ave
| Toronto |
|
M5g1y8 |
K083846 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE.
| TORONTO, ONTARIO |
|
M5G 1Y8 |
K163336 |
Luminex Molecular Diagnostics, Inc. |
439 University Ave.
| Toronto |
|
M5G 1Y8 |
K083294 |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE
| NORTHBROOK |
IL |
60062 |
K090901 |
OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE.
| PASADENA |
CA |
91105 |
K063787 |
THIRD WAVE TECHNOLOGIES, INC. |
502 SOUTH ROSA RD.
| MADISON |
WI |
53719-1256 |
K060627 |
TM BIOSCIENCE CORPORATION |
439 UNIVERSITY AVE.
| TORONTO, ONTARIO |
|
M5G 1Y8 |
DEN050004 |
TM BIOSCIENCE CORPORATION |
439 UNIVERSITY AVE., SUITE 900
| TORONTO, ONTARIO |
|
M5G 1Y8 |
|
|