The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Model 654 A Sodium, Potassium & Lithium Ise Analy.
| Device ID | K884769 |
| 510k Number | K884769 |
| Device Name: | MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY |
| Classification | Electrode, Ion Specific, Potassium |
| 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 | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-14 |
| Decision Date | 1989-01-17 |