The following data is part of a premarket notification filed by Clinical Diagnostic Systems, Inc. with the FDA for Kodak Ektacchem 950irc Analyzer.
| Device ID | K946090 |
| 510k Number | K946090 |
| Device Name: | KODAK EKTACCHEM 950IRC ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | CLINICAL DIAGNOSTIC SYSTEMS, INC. 601 LEE RD. Rochester, NY 14652 -3104 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell CLINICAL DIAGNOSTIC SYSTEMS, INC. 601 LEE RD. Rochester, NY 14652 -3104 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-01-17 |