K983997 is an FDA 510(k) clearance for the STERICHEK TOTAL CHLORINE TEST KIT. This device is classified as a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II - Special Controls, product code MSY).
Submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 2, 1999, 143 days after receiving the submission on November 10, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K983997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1998 |
| Decision Date | April 02, 1999 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSY — Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |