Genbio: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Genbio” (first 1996, latest 2001), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 286 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 4 | 4 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 2 | 2 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 1 |
Review panels
- Microbiology (10)
Most recent Genbio 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010301 | IMMUNOWELL EA (D) IGG TEST | LSE | 2001-06-11 | 130 |
| K974244 | IMMUNODOT MONO-M TEST | LSE | 1998-09-22 | 314 |
| K974226 | IMMUNODOT MONO-G TEST | LSE | 1998-09-22 | 314 |
| K973941 | IMMUNOWELL EBNA IGG TEST | LLM | 1998-08-10 | 299 |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | LSE | 1998-08-10 | 299 |
| K973939 | IMMUNOWELL VCA IGM TEST | LJN | 1998-08-10 | 299 |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | LJZ | 1997-05-05 | 272 |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | LJZ | 1997-05-02 | 269 |
| K953683 | MMUNO DOT BORRELIA DOT BLOT M TEST | LSR | 1996-05-03 | 270 |
| K953682 | IMMUNO DOT BORRELIA DOT BLOT G TEST | LSR | 1996-05-03 | 270 |
Recalls
openFDA lists no recalls under a recalling firm named Genbio.
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 Genbio?
FDA lists 10 510(k) clearances under the applicant name “Genbio” (first 1996, latest 2001), across 5 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 Genbio?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genbio is 286 days.
Which FDA product codes appear under Genbio?
The most frequent FDA product codes under this applicant name are LSE (Epstein-Barr Virus, Other, 4); LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., 2); LSR (Reagent, Borrelia Serological Reagent, 2).
Next steps
- See all 10 Genbio clearances with predicates and recalls
- Run predicate analysis for product code LSE, Genbio'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.