Medical Device Manufacturer · US , South Lyon , MI

Omega Laboratories, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2010
9
Total
9
Cleared
0
Denied

Omega Laboratories, Inc. has 9 FDA 510(k) cleared medical devices. Based in South Lyon, US.

Historical record: 9 cleared submissions from 2010 to 2015. Primary specialty: Toxicology.

Browse the FDA 510(k) cleared devices submitted by Omega Laboratories, Inc. Filter by specialty or product code using the sidebar.

9 devices
1–9 of 9
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
K142855 · DKZ Enzyme Immunoassay, Amphetamine · Toxicology
Jul 2015 301d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
K140671 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 2015 296d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128 · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Toxicology
Nov 2013 204d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
K131181 · LCM Enzyme Immunoassay, Phencyclidine · Toxicology
Jun 2013 61d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
K122759 · LDJ Enzyme Immunoassay, Cannabinoids · Toxicology
Dec 2012 86d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K112808 · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Toxicology
Jan 2012 118d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
K103161 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2011 412d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
K101973 · LAF Gas Chromatography, Methamphetamine · Chemistry
Aug 2011 399d
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
K101059 · LCM Enzyme Immunoassay, Phencyclidine · Toxicology
Jul 2010 88d
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