Data / Medical devices / United States / Omega Laboratories, Inc.

Omega Laboratories, Inc.: FDA-registered device maker in Mogadore, OH, United States, 9 510(k) clearances

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

Omega Laboratories, Inc. is registered with the FDA (registration 3004847291) in Mogadore, OH, United States. It lists 14 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 28, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004847291
Address: 400 N Cleveland Ave, Mogadore, OH, United States, 44260
Owner or operator: OMEGA LABORATORIES, INC. (9074072)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 16, 2005
Registered through: 2026
Brand names listed: Alcolizer LE5 Alcohol Tester, Drugalizer LE5 Drug Tester System, Druglizer LE5 Drug Tester System, HAIR COLLECTION KIT, Omega Laboratories Hair Drug Screening Assay

Devices it lists

Device	Product code	Class	Role	Source
Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	MPQ	1	Specification developer	accessdata.fda.gov
Devices, Breath Trapping, Alcohol	DJZ	1	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Complaint file establishment	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Complaint file establishment	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Complaint file establishment	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Complaint file establishment	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Complaint file establishment	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	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
July 28, 2015	K142855	Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)	DKZ	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
January 8, 2015	K140671	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE	DJG	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
November 13, 2013	K131128	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES	DIO	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
June 25, 2013	K131181	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE	LCM	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
December 5, 2012	K122759	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)	LDJ	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
January 23, 2012	K112808	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES	DIO	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
December 13, 2011	K103161	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES	DJG	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
August 16, 2011	K101973	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)	LAF	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov
July 12, 2010	K101059	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE	LCM	Substantially Equivalent	Omega Laboratories, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 28, 2015. 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.