The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slide Phenytoin.
| Device ID | K941142 |
| 510k Number | K941142 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester, NY 14652 -0882 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester, NY 14652 -0882 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-10 |
| Decision Date | 1994-06-13 |