WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
FDA 510(k) clearance K953854 · decided 1996-03-11
Clearance details
- K-number
- K953854
- Device name
- WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
- Applicant
- Integrated Biomedical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-07
- Decision date
- 1996-03-11
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- FKP
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NxStage Connected Health System (K181991) | Nxstage Medical, Inc. | 2018-09-26 |
| NXSTAGE CONNECTED HEALTH SYSTEM (K131739) | Nxstage Medical, Inc. | 2013-10-10 |
| NXSTAGE DOSING CALCULATOR (K130460) | Nxstage Medical, Inc. | 2013-07-11 |
| ONEVIEW INTERFACE (K040074) | Nxstage Medical, Inc. | 2004-04-08 |
| FRESENIUS ICARE MONITORING SYSTEM (K021060) | Fresenius Medical Care North America | 2002-11-13 |
| STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (K003615) | Environmental Test Systems, Inc. | 2001-02-01 |
| CKHEMO, MODEL CKHEMO VERSION 1.0 (K992255) | Csam, Inc. | 1999-11-30 |
| HIGH RANGE PEROXIDE TEST STRIP (K964264) | Integrated Biomedical Technology, Inc. | 1997-06-16 |
| PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423) | Fresenius USA, Inc. | 1996-06-13 |
| BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181) | Fresenius USA, Inc. | 1995-11-29 |
| SPS 1550 SINGLE NEEDLE PATIENT SYSTEM (K922757) | Baxter Healthcare Corp | 1995-02-13 |
| FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM (K921456) | Fresenius USA, Inc. | 1994-04-20 |
Recalls involving this device
No recalls on record reference this clearance.