The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Total Chlorine Test Kit.
| Device ID | K983997 |
| 510k Number | K983997 |
| Device Name: | STERICHEK TOTAL CHLORINE TEST KIT |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | ENVIRONMENTAL TEST SYSTEMS, INC. P.O. BOX 4659 Elkhart, IN 46514 |
| Contact | Bruce G Piekarski |
| Correspondent | Bruce G Piekarski ENVIRONMENTAL TEST SYSTEMS, INC. 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 | 1998-11-10 |
| Decision Date | 1999-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851575007068 | K983997 | 000 |
| 00851575007051 | K983997 | 000 |