Sterichek Total Chlorine Reagent Strips
FDA 510(k) K994226 · Environmental Test Systems, Inc.
510(k) numberK994226
Submission
- Device name
- Sterichek Total Chlorine Reagent Strips
- Applicant
- Environmental Test Systems, Inc.
Elkhart, IN, US - Received
- December 15, 1999
- Decision date
- March 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSY – Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243898 | Chlorine Sentinel IIMSY · Traditional | Nelson Environmental Technologies, Inc. | 04/11/2025SE |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B)MSY · Traditional | Reprocessing Products Corporation (Rpc) | 10/18/2022SE |
| K193169 | Nelson Sentinel Series Basic Chlorine SentinelMSY · Traditional | Nelson Environmental Technologies, Inc. | 10/29/2020SE |
| K132344 | E-Z Check Ozone Test StripsMSY · Traditional | Reprocessing Products Corporation (Rpc) | 02/25/2014SE |
| K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineMSY · Traditional | Reprocessing Products Corp | 05/08/2009SE |
| K080712 | Serim Hisense Ultra 0.1, Part Number 5167MSY · Traditional | Serim Research Corp. | 05/06/2008SE |
| K002011 | Glutartest 1 Reagent StripMSY · Traditional | Integrated Biomedical Technology, Inc. | 01/22/2001SE |
| K001194 | Sterichek Total Chlorine Reagent StripsMSY · Traditional | Environmental Test Systems, Inc. | 07/11/2000SE |
| K983997 | Sterichek Total Chlorine Test KitMSY · Traditional | Environmental Test Systems, Inc. | 04/02/1999SE |
| K974064 | Micro X Residual Test StripsMSY · Traditional | Reprocessing Products Corp | 12/07/1998SE |
More from Reprocessing Products Corp
| 510(k) | Device | Decision |
|---|---|---|
| K031267 | Sterichek Bicarb PH Reagent StripsMNV · Traditional | 12/23/2003SE |
| K003615 | Sterichek Sensitive-Feed Water and Rinse Water Reagent StripsFKP · Special | 02/01/2001SE |
| K001194 | Sterichek Total Chlorine Reagent StripsMSY · Traditional | 07/11/2000SE |
| 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 Total Chlorine Reagent Strips cleared by the FDA?
Sterichek Total Chlorine Reagent Strips (K994226) received a 510(k) decision of Substantially Equivalent on March 22, 2000, 98 days after the submission was received.
What is the product code of K994226?
The FDA product code is MSY – Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 876.5665.