Data / Medical devices / United States / QuickCo, LTD

QuickCo, LTD: FDA-registered device maker in Sharonville, OH, United States, 3 510(k) clearances

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

QuickCo, LTD is registered with the FDA (registration 3013684380) in Sharonville, OH, United States. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 26, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013684380
Address: 3660 Park 42 Drive, Sharonville, OH, United States, 45241
Owner or operator: QuickCo, LTD (10055005)
Roles: Repackager or relabeler
First device listed: May 24, 2017
Registered through: 2026
Brand names listed: QuickCo, Ltd. THC Test Cassette, QuickTest

Devices it lists

Device	Product code	Class	Role	Source
Bag, Urine Collecting, Ureterostomy	EXG	1	Repackager or relabeler	accessdata.fda.gov
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
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	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
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
December 11, 2014	K142800	Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard	DKZ	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
August 20, 2014	K140748	ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD	DJG	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 26, 2016. 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.