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Co-Innovation Biotech Co.,ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 5 510(k) clearances

Name: Co-Innovation Biotech Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Co-Innovation Biotech Co.,ltd. is registered with the FDA (registration 3010220539) in Guangzhou Guangdong, China. It lists 29 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 22, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010220539
Address: No. 9 Baihe 3 street, Economic and Technological Development East Zone, Guangzhou Guangdong, China, 510530
Owner or operator: Co-Innovation Biotech Co.,Ltd. (10042828)
Roles: Contract manufacturer, Manufacturer
First device listed: January 3, 2013
Registered through: 2026
Brand names listed: ACCU KNOW Urine Drug Test, Areta Ovulation Test Kit, Areta Ovulation Test Strip, Areta Pregnancy Test Strip, Cannabinoid (THC) Test System, CheckYo Ovulation Test Strip, CheckYo Pregnancy Test Midstream, CheckYo Pregnancy Test Strip and more

Devices it lists

Device	Product code	Class	Role	Source
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Manufacturer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Contract manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Contract manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Contract manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Contract manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Contract manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Contract manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Contract manufacturer	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Contract manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Contract manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Contract manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Contract manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 22, 2024	K241100	Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard	NGL	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
March 8, 2024	K231904	Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard	DJG	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
January 17, 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	LDJ	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
April 5, 2022	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	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
April 26, 2016	K153050	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	DJG	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.