The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Model 664/fast 4 System.
| Device ID | K871028 |
| 510k Number | K871028 |
| Device Name: | CIBA CORNING MODEL 664/FAST 4 SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-16 |
| Decision Date | 1987-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414194462 | K871028 | 000 |