Biomedica, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Biomedica, Inc.” (first 1982, latest 1982), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 16 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 6 | 6 |
| JSI | Culture Media, Selective And Differential | 5 | 5 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 3 | 3 |
| JSC | Culture Media, General Nutrient Broth | 2 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
Review panels
- Microbiology (19)
Most recent Biomedica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820810 | #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE | JSE | 1982-04-08 | 16 |
| K820809 | #2008 SIMMONS CITRATE | JSF | 1982-04-08 | 16 |
| K820807 | #2011 STREP SELECTIVE AGAR | JSJ | 1982-04-08 | 16 |
| K820806 | #2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL | JSJ | 1982-04-08 | 16 |
| K820805 | #2005 SABOURAUD DEXTROSE AGAR/#4002 SLA | JSJ | 1982-04-08 | 16 |
| K820804 | #2013 CNA 5% SHEEP BLOOD | JSJ | 1982-04-08 | 16 |
| K820803 | #2003 MYCOBIOTIC AGAR | JSJ | 1982-04-08 | 16 |
| K820802 | #2009 BIGGY AGAR | JSI | 1982-04-08 | 16 |
| K820801 | #2007 XLD | JSI | 1982-04-08 | 16 |
| K820800 | #2006 SALMONELLA SHIGELLA AGAR | JSI | 1982-04-08 | 16 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomedica, 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 Biomedica, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Biomedica, Inc.” (first 1982, latest 1982), across 7 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 Biomedica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedica, Inc. is 16 days.
Which FDA product codes appear under Biomedica, Inc.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 6); JSI (Culture Media, Selective And Differential, 5); JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, 3).
Next steps
- See all 19 Biomedica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Biomedica, 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 (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.