Granbio, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Granbio, Inc.” (first 1987, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 116 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 | 2 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 2 | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 | 2 |
| LSE | Epstein-Barr Virus, Other | 2 | 2 |
Review panels
- Microbiology (8)
Most recent Granbio, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | LLM | 1996-02-15 | 301 |
| K934774 | UNKNOWN | LSE | 1994-04-20 | 197 |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | LJN | 1990-09-12 | 141 |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | GNP | 1990-09-12 | 183 |
| K881617 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY | LSE | 1988-06-07 | 53 |
| K871298 | EBNA ACIF ASSAY KIT | LLM | 1987-06-25 | 86 |
| K864604 | EBV VCA IGM ANTIBODY ASSAY KIT | LJN | 1987-02-02 | 70 |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | GNP | 1987-02-02 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Granbio, 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 Granbio, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Granbio, Inc.” (first 1987, latest 1996), across 4 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 Granbio, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Granbio, Inc. is 116 days.
Which FDA product codes appear under Granbio, Inc.?
The most frequent FDA product codes under this applicant name are GNP (Antiserum, Cf, Epstein-Barr Virus, 2); LJN (Antibody Igm, If, Epstein-Barr Virus, 2); LLM (Test, Antigen, Nuclear, Epstein-Barr Virus, 2).
Next steps
- See all 8 Granbio, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GNP, Granbio, 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.