Data / Medical devices / United States / Hysen Inc

Hysen Inc: FDA-registered device maker in Cincinnati, OH, United States, 2 510(k) clearances

Name: Hysen Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hysen Inc is registered with the FDA (registration 3036649420) in Cincinnati, OH, United States. It lists 22 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 7, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3036649420
Address: 201 E 5th St Ste 1900, Cincinnati, OH, United States, 45202
Owner or operator: Hysen Inc (10092937)
Roles: Repackager or relabeler
First device listed: June 27, 2025
Registered through: 2026
Brand names listed: Assure Tech. (Hangzhou) Co., Ltd DOA CARDS, Assure Tech. (Hangzhou) Co., Ltd DOA CUP, UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

Devices it lists

Device	Product code	Class	Role	Source
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Repackager or relabeler	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Repackager or relabeler	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Repackager or relabeler	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Repackager or relabeler	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Repackager or relabeler	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Repackager or relabeler	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Repackager or relabeler	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	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
February 7, 2025	K243996	AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup	NFT	Substantially Equivalent	Assure Tech., LLC	accessdata.fda.gov
July 19, 2013	K131811	UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS	DKZ	Substantially Equivalent	Ucp Biosciences, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 7, 2025. 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.