Polymer Technology Systems, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Polymer Technology Systems, Inc.” (first 1998, latest 2016), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 45 |
| 2015 | 2 | 262 |
| 2016 | 1 | 562 |
| 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 | 7 |
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 6 |
| CGA | Glucose Oxidase, Glucose | 4 | 4 |
| JGY | Colorimetric Method, Triglycerides | 2 | 2 |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 2 | 2 |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 2 | 2 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | 1 | 1 |
Review panels
- Clinical Chemistry (27)
Most recent Polymer Technology Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | CHH | 2016-12-22 | 562 |
| K151530 | CardioChek Plus Test System | CGA | 2015-07-07 | 29 |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | NBW | 2015-05-22 | 494 |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System | CGA | 2014-10-02 | 45 |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | CHH | 2007-10-15 | 126 |
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | NBW | 2007-09-10 | 101 |
| K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | NBW | 2007-01-31 | 28 |
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | NAQ | 2006-04-05 | 28 |
| K041750 | PTS PANELS CHOL+GLU TEST PANEL | NBW | 2004-07-23 | 24 |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | MRR | 2004-07-06 | 111 |
17 earlier clearances. See the full list in Caduvo.
Recalls
25 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2020-01-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Polymer Technology Corp. (28 510(k)s)
- Polymer Technology Intl. (6 510(k)s)
- Polymer Technology Div. Wilmington Partners, L.P. (3 510(k)s)
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (3 510(k)s)
- Polymer Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymer Technology Systems, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Polymer Technology Systems, Inc.” (first 1998, latest 2016), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polymer Technology Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymer Technology Systems, Inc. is 107 days.
Which FDA product codes appear under Polymer Technology Systems, Inc.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 7); NBW (System, Test, Blood Glucose, Over The Counter, 6); CGA (Glucose Oxidase, Glucose, 4).
Next steps
- See all 27 Polymer Technology Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Polymer Technology Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.