The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Qst Amikacin Assay.
| Device ID | K840193 |
| 510k Number | K840193 |
| Device Name: | EMIT QST AMIKACIN ASSAY |
| Classification | Radioimmunoassay, Amikacin |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLQ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-18 |
| Decision Date | 1984-03-23 |