FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Amikacin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955570 | OXIS INTL., INC. |
6040 NORTH CUTTER CIR., #317 | PORTLAND | OR | 97217-3935 |
| K033884 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K052815 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268-5260 |
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