OMEGA LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048472913004847291OMEGA LABORATORIES, INC.1N2026-01-01400 N CLEVELAND AVE MOGADORE OH US 44260

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
652971598276863K142855Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)DKZ2015-07-28
652971011472924K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONEDJG2015-01-08
652971927912562K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINELCM2013-06-25
652971276032770K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESDIO2013-11-13
652971264704833K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)LDJ2012-12-05
652971976237703K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESDIO2012-01-23
652971215586098K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESDJG2011-12-13
652971816283277K101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)LAF2011-08-16
652971910636766K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINELCM2010-07-12
652971268973507
652971348057478
652971461646244
652971712882254
652971742454677
652971925291998
652971935845520
652972025863171

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG22015-01-08
DIO22013-11-13
LCM22013-06-25
DKZ12015-07-28
LDJ12012-12-05
LAF12011-08-16

PMN#