J R Scientific: FDA filings under this applicant name
FDA lists 132 510(k) clearances under the applicant name “J R Scientific” (first 1987, latest 1988), across 1 product code 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 132 | 132 |
Review panels
- Pathology (132)
Most recent J R Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | KIT | 1988-09-30 | 11 |
| K883632 | EX-CELL 300TM, CATALOG NO. 210-3575 | KIT | 1988-09-07 | 16 |
| K883631 | EX-CELL 300TM, CATALOG # 210-3579 | KIT | 1988-09-07 | 16 |
| K883630 | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | KIT | 1988-09-07 | 16 |
| K883629 | HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 | KIT | 1988-09-07 | 16 |
| K883628 | MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 | KIT | 1988-09-07 | 16 |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | KIT | 1988-09-07 | 16 |
| K883626 | EX-CELL 301, CATALOG NO. 210-3577 | KIT | 1988-09-07 | 16 |
| K883625 | EX-CELL 301, CATALOG NO. 200-3651 | KIT | 1988-09-07 | 16 |
| K883624 | EX-CELL 300TM, CATALOG NO. 200-3601 | KIT | 1988-09-07 | 16 |
122 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J R Scientific.
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 J R Scientific?
FDA lists 132 510(k) clearances under the applicant name “J R Scientific” (first 1987, latest 1988), across 1 product code 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 J R Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name J R Scientific is 16 days.
Which FDA product codes appear under J R Scientific?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 132).
Next steps
- See all 132 J R Scientific clearances with predicates and recalls
- Run predicate analysis for product code KIT, J R Scientific'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.