Shenzhen Bioeasy Biotechnology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shenzhen Bioeasy Biotechnology Co., Ltd.” (first 2018, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 46 days. Since 2017 the median was 46 days, against 58 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 |
|---|---|---|
| 2018 | 1 | 56 |
| 2019 | 2 | 28 |
| 2020 | 1 | 46 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 60 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Bioeasy Biotechnology Co., Ltd. took a median 46 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
| NFT | Test, Amphetamine, Over The Counter | 1 | 1 |
| NFW | Test, Cannabinoid, Over The Counter | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
Review panels
Most recent Shenzhen Bioeasy Biotechnology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | DJG | 2023-03-31 | 60 |
| K193480 | BIOEASY Multi-Drug Test Cup | NGL | 2020-01-31 | 46 |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | LDJ | 2019-10-11 | 28 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | NFW | 2019-09-20 | 28 |
| K182530 | BIOEASY Multi-Drug Test Cup | NFT | 2018-11-09 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Bioeasy Biotechnology Co., Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Bioeasy Biotechnology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Shenzhen Bioeasy Biotechnology Co., Ltd.” (first 2018, latest 2023), 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 Shenzhen Bioeasy Biotechnology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Bioeasy Biotechnology Co., Ltd. is 46 days. Since 2017: 46 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Bioeasy Biotechnology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 1); LDJ (Enzyme Immunoassay, Cannabinoids, 1); NFT (Test, Amphetamine, Over The Counter, 1).
Next steps
- See all 5 Shenzhen Bioeasy Biotechnology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Shenzhen Bioeasy Biotechnology Co., Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.