510(k) K980164
- Device
- STERICHEK PERACETIC ACID REAGENT STRIPS
- Applicant
- ENVIRONMENTAL TEST SYSTEMS, INC.
- 510(k) number
- K980164
- Product code
- MSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-16
- Date received
- 1998-01-16
- Regulation
- 876.5665
- Classification name
- Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUCE G PIEKARSKI
- Address
- P.O. Box 4659 Elkhart IN US 46514 46514
FDA Registration Numbers#
- 2028411
- 3029754060
- 2013736
- 2150060
- 1833387
- 3010866895
Source Documents#
Other 510(k) Records For Product Code MSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | 2025-04-11 |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | 2022-10-18 |
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | 2020-10-29 |
| K132344 | E-Z CHECK OZONE TEST STRIPS | Reprocessing Products Corporation (Rpc) | 2014-02-25 |
| K090338 | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE | Reprocessing Products Corp | 2009-05-08 |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | Serim Research Corp. | 2008-05-06 |
| K002011 | GLUTARTEST 1 REAGENT STRIP | Integrated Biomedical Technology, Inc. | 2001-01-22 |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-07-11 |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-03-22 |
| K983997 | STERICHEK TOTAL CHLORINE TEST KIT | Environmental Test Systems, Inc. | 1999-04-02 |
| K974064 | MICRO X RESIDUAL TEST STRIPS | Reprocessing Products Corp | 1998-12-07 |
| K971598 | STERICHEK CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 1997-07-18 |
Legacy Summary#
summary
FDA Review#
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