The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cybrex Amikacin.
| Device ID | K802669 |
| 510k Number | K802669 |
| Device Name: | CYBREX AMIKACIN |
| Classification | Radioimmunoassay, Amikacin |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | KLQ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-27 |
| Decision Date | 1980-11-12 |