The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides.
| Device ID | K912217 |
| 510k Number | K912217 |
| Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES |
| Classification | Colorimetry, Cholinesterase |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Norman H.geil |
| Correspondent | Norman H.geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750004225 | K912217 | 000 |
| 10758750000241 | K912217 | 000 |