Chemicon Intl., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Chemicon Intl., Inc.” (first 1995, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 602 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 |
|---|---|---|---|
| GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | 5 | 5 |
| GOE | Antisera, Fluorescent, Poliovirus 1-3 | 2 | 2 |
| LYF | Pneumocystis Carinii | 1 | 1 |
Review panels
- Microbiology (8)
Most recent Chemicon Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992252 | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | LYF | 1999-08-10 | 35 |
| K940473 | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | GOE | 1995-09-12 | 587 |
| K940027 | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | GOE | 1995-09-12 | 617 |
| K940472 | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | GNM | 1995-09-08 | 583 |
| K940471 | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | GNM | 1995-09-08 | 583 |
| K936145 | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | GNM | 1995-09-08 | 620 |
| K936089 | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY | GNM | 1995-09-08 | 626 |
| K936073 | ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS | GNM | 1995-09-08 | 627 |
Recalls
openFDA lists no recalls under a recalling firm named Chemicon Intl., 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 Chemicon Intl., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Chemicon Intl., Inc.” (first 1995, latest 1999), across 3 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 Chemicon Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chemicon Intl., Inc. is 602 days.
Which FDA product codes appear under Chemicon Intl., Inc.?
The most frequent FDA product codes under this applicant name are GNM (Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6, 5); GOE (Antisera, Fluorescent, Poliovirus 1-3, 2); LYF (Pneumocystis Carinii, 1).
Next steps
- See all 8 Chemicon Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GNM, Chemicon Intl., 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.