The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for Gentamicin Fluroimmunassay Kit.
| Device ID | K782025 |
| 510k Number | K782025 |
| Device Name: | GENTAMICIN FLUROIMMUNASSAY KIT |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | TECHNIA DIAGNOSTICS LTD. 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 | 1978-12-05 |
| Decision Date | 1979-01-26 |