Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips
FDA 510(k) K003615 · Environmental Test Systems, Inc.
510(k) numberK003615
Submission
- Device name
- Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips
- Applicant
- Environmental Test Systems, Inc.
Elkhart, IN, US - Received
- November 22, 2000
- Decision date
- February 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
| K953854 | Watercheck Reagent Strip for Chlorine & PeroxideFKP · Traditional | Integrated Biomedical Technology, Inc. | 03/11/1996SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | Fresenius USA, Inc. | 11/29/1995SE |
More from Fresenius USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K031267 | Sterichek Bicarb PH Reagent StripsMNV · Traditional | 12/23/2003SE |
| K001194 | Sterichek Total Chlorine Reagent StripsMSY · Traditional | 07/11/2000SE |
| K994226 | Sterichek Total Chlorine Reagent StripsMSY · Traditional | 03/22/2000SE |
| K983997 | Sterichek Total Chlorine Test KitMSY · Traditional | 04/02/1999SE |
| K980164 | Sterichek Peracetic Acid Reagent StripsMSY · Traditional | 04/16/1998SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | 03/20/1998SE |
| K971598 | Sterichek Chlorine Reagent StripsMSY · Traditional | 07/18/1997SE |
Questions and answers
When was Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips cleared by the FDA?
Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips (K003615) received a 510(k) decision of Substantially Equivalent on February 1, 2001, 71 days after the submission was received.
What is the product code of K003615?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.