The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Ektachem Clinical Chem. Slides.
| Device ID | K840606 |
| 510k Number | K840606 |
| Device Name: | EKTACHEM CLINICAL CHEM. SLIDES |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | EASTMAN KODAK COMPANY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-10 |
| Decision Date | 1984-04-04 |