The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slide For Asparate Amimotransferase.
| Device ID | K934413 |
| 510k Number | K934413 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1994-04-25 |