FDA 510(k) Applications for Medical Device:
Instrumentation For Clinical Multiplex Test Systems
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| DEN040012 | Affymetrix, Inc. |
3380 CENTRAL EXPRESSWAY | SANTA CLARA | CA | 95051 |
| K080995 | Affymetrix, Inc. |
3420 Central Expressway | Santa Clara | CA | 95051 |
| K082562 | APPLIED BIOSYSTEMS INC |
850 LINCOLN CENTER DRIVE | FOSTER CITY | CA | 94404-1128 |
| K143178 | BioFire Diagnostics, LLC |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K110786 | GENMARK DIAGNOSTICS, INC |
5964 LA PLACE COURT | CARLSBAD | CA | 92008 |
| K163652 | GenMark Diagnostics, Incorporated |
5964 La Place Court | Carlsbad | CA | 92008 |
| K093128 | ILLUMINA, INC. |
5200 ILLUMINA WAY | SAN DIEGO | CA | 92122 |
| K133849 | LIPOSCIENCE |
2500 SUMMER BLVD. | RALEIGH | NC | 27616 |
| K133302 | LUMINEX CORP. |
12212 TECHNOLOGY BLVD. | AUSTIN | TX | 78727-6115 |
| K121399 | LUMINEX CORP. |
12212 Technology Blvd | AUSTIN | TX | 78727 |
| K073506 | LUMINEX CORP. |
439 UNIVERSITY AVENUE SUITE | TORONTO | M5G 1Y8 | |
| K070597 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K141220 | THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN |
BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, NO. 07-06 | SINGAPORE | 739256 |
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