FDA 510(k) Applications for Medical Device:
Reagent/Device, Inoculum Calibration
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K221493 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K103456 | TREK DIAGNOSTIC SYSTEMS |
982 KEYNOTE CIRCLE | CLEVELAND | OH | 44131 |
| K110331 | TREK DIAGNOSTIC SYSTEMS, LTD. |
982 KEYNOTE CIRCLE | CLEVELAND | OH | 44131 |
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