Bestgen Biotech Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bestgen Biotech Corp.” (first 2008, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 496 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 | 4 | 524 |
| 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
Review panels
Most recent Bestgen Biotech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103230 | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | CGA | 2012-04-24 | 540 |
| K103116 | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2012-03-13 | 509 |
| K103044 | AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | NBW | 2012-02-10 | 484 |
| K100437 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION | NBW | 2012-01-12 | 694 |
| K090389 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2009-07-14 | 147 |
| K072274 | MAJOR III BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-02-29 | 198 |
Recalls
openFDA lists no recalls under a recalling firm named Bestgen Biotech Corp..
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 Bestgen Biotech Corp.?
FDA lists 6 510(k) clearances under the applicant name “Bestgen Biotech Corp.” (first 2008, latest 2012), across 2 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 Bestgen Biotech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bestgen Biotech Corp. is 496 days.
Which FDA product codes appear under Bestgen Biotech Corp.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 4); CGA (Glucose Oxidase, Glucose, 2).
Next steps
- See all 6 Bestgen Biotech Corp. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Bestgen Biotech Corp.'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.