# Co-Innovation Biotech Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 10 (2013–2024): 10 510(k) clearances
- Product codes: DJG (3), DKZ (2), LCX (2), NGL (1), LDJ (1), DIS (1)
- 510(k) review time since 2016: median 120 days, against 150 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 13 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advin Biotech, Inc.: 2 (https://510kreport.com/company/advin-biotech)
- Ucp Biosciences, Inc.: 2 (https://510kreport.com/company/ucp-biosciences)
- Shenzhen Bioeasy Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bioeasy-biotechnology)
- Blue Cross Bio-Medical Co., Ltd.: 1 (https://510kreport.com/company/blue-cross-bio-medical)
- Shenzhen Superbio Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-superbio-technology)

## Firms that cite its devices most
- W.H.P.M., Inc.: 2 (https://510kreport.com/company/whpm)
- Shanghai Accurature Diagnostics Co., Ltd.: 1 (https://510kreport.com/company/shanghai-accurature-diagnostics)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)
- Atlas Medical: 1 (https://510kreport.com/company/atlas-medical)
- Assure Tech. (Hangzhou) Co, Ltd.: 1 (https://510kreport.com/company/assure-tech-hangzhou)
- Xenta Biomedical Science Co., Ltd.: 1 (https://510kreport.com/company/xenta-biomedical-science)
- Shenzhen Bioeasy Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bioeasy-biotechnology)
- Weihai Kangzhou Biotechnology Engineering Co., Ltd.: 1 (https://510kreport.com/company/weihai-kangzhou-biotechnology-engineering)

## Its most-cited devices
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (2016), cited by 5
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), cited by 3
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), cited by 2
- K132085: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream (2013), cited by 2
- K231904: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (2024), cited by 1

## Recent decisions
- K241100: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (May 22, 2024)
- K231904: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (Mar 8, 2024)
- 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 (Jan 17, 2024)
- 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 (Apr 5, 2022)
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (Apr 26, 2016)
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (Dec 11, 2014)
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (Aug 20, 2014)
- K140215: One Step Single/Multi-Drug Test Cup/Dipcard (Jun 16, 2014)

Source page: https://510kreport.com/company/co-innovation-biotech