Agen Biomedical , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Agen Biomedical , Ltd.” (first 1988, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 3 | 3 |
| GHH | Fibrin Split Products | 3 | 3 |
Review panels
- Hematology (6)
Most recent Agen Biomedical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | GHH | 1999-12-14 | 75 |
| K974596 | DIMERTEST LATEX ASSAY | DAP | 1998-05-26 | 168 |
| K945642 | AGEN DIMERTEST GOLD EIA | GHH | 1995-10-25 | 343 |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | GHH | 1991-04-12 | 116 |
| K890189 | AGEN DIMERTEST EIA | DAP | 1989-03-03 | 45 |
| K882944 | DIMERTEST(R) LATEX | DAP | 1988-08-17 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Agen Biomedical , Ltd..
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 Agen Biomedical , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Agen Biomedical , Ltd.” (first 1988, latest 1999), across 2 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 Agen Biomedical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agen Biomedical , Ltd. is 96 days.
Which FDA product codes appear under Agen Biomedical , Ltd.?
The most frequent FDA product codes under this applicant name are DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, 3); GHH (Fibrin Split Products, 3).
Next steps
- See all 6 Agen Biomedical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DAP, Agen Biomedical , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.