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Qingdao Hightop Biotech Co., Ltd.: FDA-registered device maker in Qingdao Shandong, China, 3 510(k) clearances

Name: Qingdao Hightop Biotech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Qingdao Hightop Biotech Co., Ltd. is registered with the FDA (registration 3014223276) in Qingdao Shandong, China. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 14, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014223276
Address: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao Shandong, China, 266112
Owner or operator: Qingdao HIGHTOP Biotech Co., Ltd. (10061479)
Roles: Manufacturer
First device listed: October 22, 2019
Registered through: 2026
Brand names listed: FSH Rapid Test, HIGHTOP (LH) Luteinizing Hormone Rapid Test Cassette, HIGHTOP (LH) Luteinizing Hormone Rapid Test Midstream, HIGHTOP (LH) Luteinizing Hormone Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Midstream, HIGHTOP Pregnancy Rapid Test Strip, Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel and more

Devices it lists

Device	Product code	Class	Role	Source
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	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, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	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
August 14, 2024	K241969	Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel	NGL	Substantially Equivalent	Qingdao Hightop Biotech Co., Ltd.	accessdata.fda.gov
May 5, 2022	K220685	HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx	NFT	Substantially Equivalent	Qingdao Hightop Biotech Co., Ltd.	accessdata.fda.gov
September 5, 2019	K192123	HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream	LCX	Substantially Equivalent	Qingdao Hightop Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 14, 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.