The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Phenytoin Fluorescent Immunoassay.
| Device ID | K813538 |
| 510k Number | K813538 |
| Device Name: | PHENYTOIN FLUORESCENT IMMUNOASSAY |
| Classification | Fluorescent Immunoassay, Diphenylhydantoin |
| Applicant | AMERICAN DIAGNOSTIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LES |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-21 |
| Decision Date | 1981-12-31 |