The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem 250 Analyer.
| Device ID | K922072 |
| 510k Number | K922072 |
| Device Name: | KODAK EKTACHEM 250 ANALYER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Yvonne Adair |
| Correspondent | Yvonne Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750009763 | K922072 | 000 |
| 10758750002054 | K922072 | 000 |
| 10758750001330 | K922072 | 000 |