The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Advance Syst. Emit-amd Gent. Assay.
| Device ID | K820285 |
| 510k Number | K820285 |
| Device Name: | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-02-18 |