The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Model 644 Sweat Diluent.
| Device ID | K935228 |
| 510k Number | K935228 |
| Device Name: | MODEL 644 SWEAT DILUENT |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-08-01 |