Data / Medical devices / United States / 2san LLC

2san LLC: FDA-registered device maker in New York, NY, United States, 5 510(k) clearances

Name: 2san LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

2san LLC is registered with the FDA (registration 3025041446) in New York, NY, United States. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 26, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3025041446
Address: 1330 Avenue of the Americas, New York, NY, United States, 10019
Owner or operator: 2San LLC (10088220)
Roles: Complaint file establishment
First device listed: June 12, 2023
Registered through: 2027
Brand names listed: 2SAN Fentanyl Urine Test Cassette, 2San Colorectal Cancer Test, 2San Home Drug Test - 1 Panel (COC), 2San Home Drug Test - 1 Panel (THC), 2San Home Drug Test - 14 Panel, 2San Home Drug Test - 4 Panel, 2San Home Drug Test - 7 Panel, 2San Urinary Tract Infection (UTI) Test and more

Devices it lists

Device	Product code	Class	Role	Source
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment	accessdata.fda.gov
Paper, Obstetric Ph	LNW	1	Complaint file establishment	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Complaint file establishment	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Complaint file establishment	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Complaint file establishment	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Complaint file establishment	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Complaint file establishment	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Complaint file establishment	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Complaint file establishment	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Complaint file establishment	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Complaint file establishment	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Complaint file establishment	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Complaint file establishment	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Complaint file establishment	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
October 26, 2023	K233417	AllTest Fentanyl Urine Test Cassette	NGL	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
June 16, 2023	K231045	Healgen URS Test Strips	LJX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
December 3, 2018	K182701	Wondfo T-Cup Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
May 14, 2017	K162333	Wondfo One Step Fecal Occult Blood (FOB) Test	KHE	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
February 17, 2011	K100024	TECO DIAGNOSTICS UTI DETECTION STRIPS	JMT	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov

Compare with other makers

Updated October 26, 2023. 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.