The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Model 560 Express Clinical Chemistry Analyzer.
| Device ID | K915366 |
| 510k Number | K915366 |
| Device Name: | MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1992-03-17 |