Data / Medical devices / China / Weihai Kangzhou Biotechnology Engineering Co., Ltd.

Weihai Kangzhou Biotechnology Engineering Co., Ltd.: FDA-registered device maker in Weihai Shandong, China, 1 510(k) clearance

Name: Weihai Kangzhou Biotechnology Engineering Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Weihai Kangzhou Biotechnology Engineering Co., Ltd. is registered with the FDA (registration 3014171027) in Weihai Shandong, China. It lists 24 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2019. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Weihai Kangzhou Biotechnology Engineering Co., Ltd.

FDA registration number: 3014171027
Address: (Room, Building B, Innovation Base) No. 213-3, Huoju Road, Weihai Shandong, China, 264205
Owner or operator: Weihai Kangzhou Biotechnology Engineering Co., Ltd. (10056397)
Roles: Manufacturer
First device listed: December 6, 2017
Registered through: 2026
Brand names listed: Barbiturates test strip/cassette/cup, Benzodiazepines test strip/cassette/cup, CAPILARRY BLOOD COLLECTION TUBE, Cocaine test strip/cassette/cup, Disinfectant wipes, Multi purpose antibacterial, Alcohol Wipes, Disposable Sampling swab, FACE MASK, FSH TEST and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Antigens, All Groups, Salmonella Spp.	GRL	2	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Dress, Surgical	FYE	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Kit, Screening, Urine	JXA	1	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, Exempt	PVE	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Manufacturer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	PVK	2	Manufacturer	accessdata.fda.gov
Tube, Collection, Capillary Blood	GIO	1	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
January 10, 2019	K183097	Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream	LCX	Substantially Equivalent	Weihai Kangzhou Biotechnology Engineering Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 10, 2019. 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.