The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Amikacin.
| Device ID | K033884 |
| 510k Number | K033884 |
| Device Name: | RANDOX AMIKACIN |
| Classification | Radioimmunoassay, Amikacin |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | KLQ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-06-09 |