The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Phenytoin.
| Device ID | K841706 |
| 510k Number | K841706 |
| Device Name: | INNOFLUOR PHENYTOIN |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | INNOTRON DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-05-22 |