The following data is part of a premarket notification filed by Monitor Science Corp. with the FDA for Bio-monitor Amikacin.
| Device ID | K780949 |
| 510k Number | K780949 |
| Device Name: | BIO-MONITOR AMIKACIN |
| Classification | Amikacin Serum Assay |
| Applicant | MONITOR SCIENCE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLP |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-09 |
| Decision Date | 1978-08-14 |