Environmental Test Systems, Inc.: FDA clearances and approvals
Environmental Test Systems, Inc. has 8 FDA 510(k) clearances (first 1997, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | 5 | 5 |
| FKP | System, Dialysate Delivery, Single Patient | 1 | 1 |
| LIF | Dialyzer Reprocessing System | 1 | 1 |
| MNV | Strip, Dialysate Ph Indicator | 1 | 1 |
Review panels
Most recent Environmental Test Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | MNV | 2003-12-23 | 246 |
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS | FKP | 2001-02-01 | 71 |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | MSY | 2000-07-11 | 90 |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | MSY | 2000-03-22 | 98 |
| K983997 | STERICHEK TOTAL CHLORINE TEST KIT | MSY | 1999-04-02 | 143 |
| K980164 | STERICHEK PERACETIC ACID REAGENT STRIPS | MSY | 1998-04-16 | 90 |
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | LIF | 1998-03-20 | 88 |
| K971598 | STERICHEK CHLORINE REAGENT STRIPS | MSY | 1997-07-18 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Environmental Test Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Environmental Test Systems, Inc. have?
Environmental Test Systems, Inc. has 8 FDA 510(k) clearances (first 1997, latest 2003), across 4 product codes in 1 review panel.
How long does FDA take to clear Environmental Test Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Environmental Test Systems, Inc.'s cleared 510(k)s is 90 days.
What devices does Environmental Test Systems, Inc. make?
Its most frequent FDA product codes are MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, 5); FKP (System, Dialysate Delivery, Single Patient, 1); LIF (Dialyzer Reprocessing System, 1).
Has Environmental Test Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Environmental Test Systems, Inc. Related entities may recall under other names.
Next steps
- See all 8 Environmental Test Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSY, Environmental Test Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.