The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Total Chlorine Reagent Strips.
| Device ID | K001194 |
| 510k Number | K001194 |
| Device Name: | STERICHEK TOTAL CHLORINE REAGENT STRIPS |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 Elkhart, IN 46514 |
| Contact | David A Morris |
| Correspondent | David A Morris ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 Elkhart, IN 46514 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-12 |
| Decision Date | 2000-07-11 |