The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Extachem Clinical Chemistry Slides (fe).
| Device ID | K910143 |
| 510k Number | K910143 |
| Device Name: | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) |
| Classification | Photometric Method, Iron (non-heme) |
| 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 | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750009244 | K910143 | 000 |
| 10758750000289 | K910143 | 000 |