Roseville Medical Laboratoriesu: FDA clearances and approvals
Roseville Medical Laboratoriesu has 8 FDA 510(k) clearances (first 1985, latest 1985), across 8 product codes in 2 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSI | Culture Media, Selective And Differential | 1 | 1 |
| JSK | Supplement, Culture Media | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
| KZI | Culture Media, Enriched | 1 | 1 |
| PPM | General Purpose Reagent | 1 | 1 |
Review panels
- Microbiology (7)
- Pathology (1)
Most recent Roseville Medical Laboratoriesu 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | JSK | 1985-03-20 | 28 |
| K850737 | TRANSPORT CULTURE MEDIUM | PPM | 1985-03-20 | 28 |
| K850736 | SELECTIVE CULTURE MEDIUM | JSI | 1985-03-20 | 28 |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | JSE | 1985-03-20 | 28 |
| K850733 | MULTIPURPOSE CULTURE MEDIUM | JSG | 1985-03-20 | 28 |
| K850732 | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI | JTY | 1985-03-20 | 28 |
| K850731 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING | JTZ | 1985-03-20 | 28 |
| K850735 | ENRICHED CULTURE MEDIUM | KZI | 1985-03-16 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Roseville Medical Laboratoriesu.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Roseville Medical Laboratoriesu have?
Roseville Medical Laboratoriesu has 8 FDA 510(k) clearances (first 1985, latest 1985), across 8 product codes in 2 review panels.
How long does FDA take to clear Roseville Medical Laboratoriesu's 510(k)s?
The median time from FDA receipt to decision across Roseville Medical Laboratoriesu's cleared 510(k)s is 28 days.
What devices does Roseville Medical Laboratoriesu make?
Its most frequent FDA product codes are JSE (Culture Media, Multiple Biochemical Test, 1); JSG (Culture Media, Non-Selective And Non-Differential, 1); JSI (Culture Media, Selective And Differential, 1).
Has Roseville Medical Laboratoriesu had device recalls?
openFDA lists no recalls under a recalling firm name matching Roseville Medical Laboratoriesu. Related entities may recall under other names.
Next steps
- See all 8 Roseville Medical Laboratoriesu clearances with predicates and recalls
- Run predicate analysis for product code JSE, Roseville Medical Laboratoriesu's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.