Tyson Bioresearch, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Tyson Bioresearch, Inc.” (first 2006, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 208 days. Since 2017 the median was 122 days, against 223 days for all cleared 510(k)s in the same product codes. 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 | 1 | 323 |
| 2013 | 1 | 260 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 269 |
| 2018 | 2 | 122 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tyson Bioresearch, Inc. took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 13 | 13 |
Review panels
- Clinical Chemistry (13)
Most recent Tyson Bioresearch, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | NBW | 2018-11-30 | 122 |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | NBW | 2018-11-29 | 121 |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System | NBW | 2017-10-06 | 269 |
| K123087 | TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-06-18 | 260 |
| K112916 | TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM | NBW | 2012-08-21 | 323 |
| K101543 | TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 | NBW | 2011-08-30 | 453 |
| K090629 | EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS | NBW | 2009-06-04 | 87 |
| K081726 | TYSONBIO LINK HEALTH MANAGEMENT SYSTEM | NBW | 2008-08-26 | 69 |
| K072854 | DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-06-30 | 269 |
| K073492 | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-04-08 | 118 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tyson Bioresearch, 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 Tyson Bioresearch, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Tyson Bioresearch, Inc.” (first 2006, latest 2018), 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 Tyson Bioresearch, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tyson Bioresearch, Inc. is 208 days. Since 2017: 122 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tyson Bioresearch, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 13).
Next steps
- See all 13 Tyson Bioresearch, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Tyson Bioresearch, 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.