ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
FDA 510(k) clearance K090338 · decided 2009-05-08
Clearance details
- K-number
- K090338
- Device name
- ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
- Applicant
- Reprocessing Products Corp
- Decision
- Substantially Equivalent
- Date received
- 2009-02-10
- Decision date
- 2009-05-08
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- MSY
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, 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 |
|---|---|---|
| Chlorine Sentinel II (K243898) | Nelson Environmental Technologies, Inc. | 2025-04-11 |
| E-Z Chek Chlorine Residual Test Strips (K100-0101B) (K222167) | Reprocessing Products Corporation (Rpc) | 2022-10-18 |
| Nelson Sentinel Series Basic Chlorine Sentinel (K193169) | Nelson Environmental Technologies, Inc. | 2020-10-29 |
| E-Z CHECK OZONE TEST STRIPS (K132344) | Reprocessing Products Corporation (Rpc) | 2014-02-25 |
| SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (K080712) | Serim Research Corp. | 2008-05-06 |
| GLUTARTEST 1 REAGENT STRIP (K002011) | Integrated Biomedical Technology, Inc. | 2001-01-22 |
| STERICHEK TOTAL CHLORINE REAGENT STRIPS (K001194) | Environmental Test Systems, Inc. | 2000-07-11 |
| STERICHEK TOTAL CHLORINE REAGENT STRIPS (K994226) | Environmental Test Systems, Inc. | 2000-03-22 |
| STERICHEK TOTAL CHLORINE TEST KIT (K983997) | Environmental Test Systems, Inc. | 1999-04-02 |
| MICRO X RESIDUAL TEST STRIPS (K974064) | Reprocessing Products Corp | 1998-12-07 |
| STERICHEK PERACETIC ACID REAGENT STRIPS (K980164) | Environmental Test Systems, Inc. | 1998-04-16 |
| STERICHEK CHLORINE REAGENT STRIPS (K971598) | Environmental Test Systems, Inc. | 1997-07-18 |
Recalls involving this device
No recalls on record reference this clearance.