Chem-Elec, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Chem-Elec, Inc.” (first 1981, latest 1996), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JFS | Coulometric, Chloride | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
Review panels
Most recent Chem-Elec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943503 | CHEMCARD GLUCOSE TEST | CGA | 1996-07-23 | 734 |
| K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | CHH | 1988-06-10 | 596 |
| K811406 | CREATININE RATE REAGENT KIT | CGX | 1981-08-13 | 86 |
| K811381 | ASTRA | JFL | 1981-08-13 | 90 |
| K811319 | CHLORIDE REAGENT KIT | JFS | 1981-08-13 | 93 |
| K811165 | GLUCOSE OXIDASE RATE REAGENT | CGA | 1981-08-13 | 107 |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | CEM | 1981-07-10 | 60 |
| K811193 | BUN RATE REAGENT | CDS | 1981-07-10 | 71 |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | JFS | 1981-07-01 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Chem-Elec, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chem-Elec, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Chem-Elec, Inc.” (first 1981, latest 1996), across 7 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 Chem-Elec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chem-Elec, Inc. is 90 days.
Which FDA product codes appear under Chem-Elec, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 2); JFS (Coulometric, Chloride, 2); CDS (Electrode, Ion Specific, Urea Nitrogen, 1).
Next steps
- See all 9 Chem-Elec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Chem-Elec, 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.