The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innoflour Gentamicin.
| Device ID | K841865 |
| 510k Number | K841865 |
| Device Name: | INNOFLOUR GENTAMICIN |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | INNOTRON DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-04 |
| Decision Date | 1984-05-31 |