The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (theo).
| Device ID | K861367 |
| 510k Number | K861367 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Philip J Harter |
| Correspondent | Philip J Harter EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-05-29 |