Biomedia, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Biomedia, Inc.” (first 1979, latest 1982), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 23 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 8 | 8 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 5 | 5 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 3 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
Review panels
- Microbiology (19)
Most recent Biomedia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821300 | #2010 CAMPHYLOBACTER AGAR | JSI | 1982-06-02 | 29 |
| K821302 | #50003 QUAD DIAGNOSTIC SYSTEM | JSH | 1982-06-01 | 28 |
| K821301 | #50002 QUAD DIAGNOSTIC SYSTEM | JSI | 1982-06-01 | 28 |
| K821108 | BI PLATE-XLD/HEKTOEN #30012 | JSI | 1982-05-13 | 23 |
| K811479 | CHODOLATE AGAR, ENRICHED | JTY | 1981-06-18 | 23 |
| K811478 | EMB AGAR, LEVINE | JSI | 1981-06-18 | 23 |
| K811477 | MACCONKEY AGAR | JSI | 1981-06-18 | 23 |
| K811476 | THAYER MARTIN AGAR | JTY | 1981-06-18 | 23 |
| K811475 | TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD | JSG | 1981-06-18 | 23 |
| K811474 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB | JSI | 1981-06-18 | 23 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomedia, 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 Biomedia, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Biomedia, Inc.” (first 1979, latest 1982), across 6 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 Biomedia, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedia, Inc. is 23 days.
Which FDA product codes appear under Biomedia, Inc.?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 8); JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, 5); JTY (Culture Media, For Isolation Of Pathogenic Neisseria, 3).
Next steps
- See all 19 Biomedia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, Biomedia, 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.