K935228 is an FDA 510(k) clearance for the MODEL 644 SWEAT DILUENT. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 1, 1994, 273 days after receiving the submission on November 1, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K935228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1993 |
| Decision Date | August 01, 1994 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |