The following data is part of a premarket notification filed by Integrated Biomedical Technology, Inc. with the FDA for Watercheck Reagent Strip For Chlorine & Peroxide.
| Device ID | K953854 |
| 510k Number | K953854 |
| Device Name: | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | INTEGRATED BIOMEDICAL TECHNOLOGY, INC. 51819 WINDING WATERS LN. Elkhart, IN 46514 |
| Contact | Wen H Wu |
| Correspondent | Wen H Wu INTEGRATED BIOMEDICAL TECHNOLOGY, INC. 51819 WINDING WATERS LN. Elkhart, IN 46514 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-03-11 |
| Summary: | summary |