Redwood Biotech, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Redwood Biotech, Inc.” (first 1999, latest 2000), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Redwood Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000979 | REDI-SCREEN | LAF | 2000-04-10 | 14 |
| K993100 | REDI-SCREEN | DJC | 1999-10-06 | 20 |
| K991698 | REDI-TEST PCP | LCM | 1999-08-25 | 99 |
| K991110 | REDI-TEST COCAINE | DIO | 1999-07-26 | 116 |
| K991504 | REDI-TEST METHAMPHETAMINE | LAF | 1999-07-22 | 84 |
| K990870 | REDI-TEST THC | LDJ | 1999-04-27 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Redwood Biotech, 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 Redwood Biotech, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Redwood Biotech, Inc.” (first 1999, latest 2000), across 5 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 Redwood Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Redwood Biotech, Inc. is 63 days.
Which FDA product codes appear under Redwood Biotech, Inc.?
The most frequent FDA product codes under this applicant name are LAF (Gas Chromatography, Methamphetamine, 2); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DJC (Thin Layer Chromatography, Methamphetamine, 1).
Next steps
- See all 6 Redwood Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LAF, Redwood Biotech, 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.