The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Sensitive-feed Water And Rinse Water Reagent Strips.
| Device ID | K003615 |
| 510k Number | K003615 |
| Device Name: | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS |
| Classification | System, Dialysate Delivery, Single Patient |
| 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 | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-02-01 |