The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Chlorine Reagent Strips.
| Device ID | K971598 |
| 510k Number | K971598 |
| Device Name: | STERICHEK CHLORINE REAGENT STRIPS |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 P.O.BOX 4659 Elkhart, IN 46514 |
| Contact | David A Morris |
| Correspondent | David A Morris ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 P.O.BOX 4659 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 | 1997-05-01 |
| Decision Date | 1997-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851575007020 | K971598 | 000 |