Co-Innovation Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Co-Innovation Biotech Co., Ltd.” (first 2013, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 136 days. Since 2017 the median was 126 days, against 120 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 |
|---|---|---|
| 2013 | 1 | 130 |
| 2014 | 4 | 144 |
| 2015 | 0 | — |
| 2016 | 1 | 189 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 120 |
| 2023 | 0 | — |
| 2024 | 3 | 132 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Co-Innovation Biotech Co., Ltd. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
Review panels
Most recent Co-Innovation Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | NGL | 2024-05-22 | 30 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | DJG | 2024-03-08 | 254 |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | LDJ | 2024-01-17 | 132 |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | LCX | 2022-04-05 | 120 |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | DJG | 2016-04-26 | 189 |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | DKZ | 2014-12-11 | 73 |
| K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD | DJG | 2014-08-20 | 148 |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | DIS | 2014-06-16 | 139 |
| K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | DKZ | 2014-01-15 | 271 |
| K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | LCX | 2013-11-12 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Co-Innovation Biotech 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Co-Innovation Biotech Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Co-Innovation Biotech Co., Ltd.” (first 2013, latest 2024), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Co-Innovation Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Co-Innovation Biotech Co., Ltd. is 136 days. Since 2017: 126 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Co-Innovation Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 3); DKZ (Enzyme Immunoassay, Amphetamine, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2).
Next steps
- See all 10 Co-Innovation Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Co-Innovation Biotech 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, 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.