FDA 510(k) Applications for Medical Device:
Susceptibility Test Plate, Antifungal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040560 | AB BIODISK |
DALVAGEN 10 | SOLNA | 16956 | |
| K082534 | AB BIOMERIEUX |
DALVAGEN 10 | SOLNA | 16956 | |
| K151817 | BIOMERIEUX INC |
595 ANGLUM ROAD | HAZELWOOD | MO | 63042 |
| K133817 | BIOMERIEUX, INC. |
100 RODOLPHE ST | DURHAM | NC | 27712 |
| K133952 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K151923 | BIOMERIEUX, INC. |
595 Anglum Road | Hazelwood | MO | 63042 |
| K061945 | BIOMERIEUX, INC. |
595 ANGLUM DR. | HAZELWOOD | MO | 63042-2320 |
| K181368 | bioMerieux, Inc. |
595 Anglum Rd. | Hazelwood | MO | 63042 |
| K101566 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K092454 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K221198 | Thermo Fisher Scientific |
1 Thermo Fisher Way | Oakwood Village | OH | 44146 |
| K211539 | Thermo Fisher Scientific |
1 Thermo Fisher Way | Oakwood Village | OH | 44146 |
| K221899 | Thermo Fisher Scientific |
1 Thermo Fisher Way | Oakwood Village | OH | 44146 |
| K231433 | Thermo Fisher Scientific |
1 Thermo Fisher Way | Oakwood Village | OH | 44146 |
| K133038 | TREK DIAGNOSTIC SYSTEMS |
1 Thermo Fisher Way | Oakwood Village | OH | 44146 |
| K991810 | TREK DIAGNOSTIC SYSTEMS, INC. |
29299 CLEMENS RD., SUITE 1-K | WESTLAKE | OH | 44145 |
| K090968 | TREK DIAGNOSTIC SYSTEMS, INC. |
982 KEYNOTE CIRCLE SUITE 6 | CLEVELAND | OH | 44131 |
| K081063 | TREK DIAGNOSTIC SYSTEMS, INC. |
982 KEYNOTE CIRCLE SUITE 6 | CLEVELAND | OH | 44131 |
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