Polymer Technology Intl.: FDA clearances and approvals
Polymer Technology Intl. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time: 312 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 2 | 2 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
Review panels
Most recent Polymer Technology Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | JMT | 1996-07-01 | 329 |
| K953662 | FIRST CHOICE KETONES URINE TEST STRIPS | JIN | 1996-06-14 | 312 |
| K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS | JIL | 1996-06-14 | 312 |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | JIN | 1996-06-12 | 310 |
| K950628 | FIRST CHOICE TEST STRIP | CGA | 1995-11-08 | 268 |
| K946166 | FIRST CHOICE(TM) TEST STRIP | CGA | 1995-11-08 | 324 |
Recalls
openFDA lists no recalls under a recalling firm named Polymer Technology Intl..
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 Polymer Technology Intl. have?
Polymer Technology Intl. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 4 product codes in 1 review panel.
How long does FDA take to clear Polymer Technology Intl.'s 510(k)s?
The median time from FDA receipt to decision across Polymer Technology Intl.'s cleared 510(k)s is 312 days.
What devices does Polymer Technology Intl. make?
Its most frequent FDA product codes are CGA (Glucose Oxidase, Glucose, 2); JIN (Nitroprusside, Ketones (Urinary, Non-Quant.), 2); JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 1).
Has Polymer Technology Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Polymer Technology Intl. Related entities may recall under other names.
Next steps
- See all 6 Polymer Technology Intl. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Polymer Technology Intl.'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.