Watercheck Reagent Strip for Chlorine & Peroxide
FDA 510(k) K953854 · Integrated Biomedical Technology, Inc.
510(k) numberK953854
Submission
- Device name
- Watercheck Reagent Strip for Chlorine & Peroxide
- Applicant
- Integrated Biomedical Technology, Inc.
Elkhart, IN, US - Received
- August 7, 1995
- Decision date
- March 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K021060 | Fresenius Icare Monitoring SystemFKP · Traditional | Fresenius Medical Care North America | 11/13/2002SE |
| K003615 | Sterichek Sensitive-Feed Water and Rinse Water Reagent StripsFKP · Special | Environmental Test Systems, Inc. | 02/01/2001SE |
| K992255 | Ckhemo, Model Ckhemo Version 1.0FKP · Traditional | Csam, Inc. | 11/30/1999SE |
| K964264 | High Range Peroxide Test StripFKP · Traditional | Integrated Biomedical Technology, Inc. | 06/16/1997SE |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | Fresenius USA, Inc. | 06/13/1996SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | Fresenius USA, Inc. | 11/29/1995SE |
More from Fresenius USA, Inc.
Questions and answers
When was Watercheck Reagent Strip for Chlorine & Peroxide cleared by the FDA?
Watercheck Reagent Strip for Chlorine & Peroxide (K953854) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 217 days after the submission was received.
What is the product code of K953854?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.