Polymedco, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Polymedco, Inc.” (first 1992, latest 2011), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 110 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 | 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (11)
- Hematology (4)
- Immunology (4)
Most recent Polymedco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112408 | POLY-CHEM 90 ISE MODULE | CEM | 2011-11-04 | 74 |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | CIX | 2011-09-08 | 168 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | CIG | 2011-09-01 | 132 |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | LBS | 2010-09-28 | 214 |
| K090703 | POLY-CHEM 90 GLUCOSE | CFR | 2009-10-20 | 217 |
| K061944 | POLY-CHEM CREATININE | JFY | 2006-11-03 | 116 |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | DCF | 2006-03-09 | 79 |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | 2004-10-21 | 147 |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | KHE | 2004-08-12 | 90 |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | LPS | 2004-02-04 | 70 |
9 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-02-12.
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.
- Polymedco Cancer Diagnostics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymedco, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Polymedco, Inc.” (first 1992, latest 2011), across 16 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polymedco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymedco, Inc. is 110 days.
Which FDA product codes appear under Polymedco, Inc.?
The most frequent FDA product codes under this applicant name are CFR (Hexokinase, Glucose, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); LCP (Assay, Glycosylated Hemoglobin, 2).
Next steps
- See all 19 Polymedco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFR, Polymedco, 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.