The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clin. Chem. Slides (amyl).
| Device ID | K812027 |
| 510k Number | K812027 |
| Device Name: | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) |
| Classification | Starch-dye Bound Polymer, Amylase |
| Applicant | EASTMAN KODAK COMPANY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CIW |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-20 |
| Decision Date | 1981-08-03 |