Omega Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Omega Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Omega Laboratories Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004847291
FEI Number3004847291
NameOMEGA LABORATORIES, INC.
Owner & OperatorOMEGA LABORATORIES, INC.
Contact Address400 NORTH CLEVELAND --
Mogadore OH 44260 US
Official Correspondent
  • Bill - Corl
  • x-330-6285748-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 N CLEVELAND AVE
MOGADORE, OH 44260 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Omega Laboratories Hair Drug Screening Assay2019-11-19
OMEGA LABORATORIES, INC.
Druglizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Druglizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Druglizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Druglizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Druglizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Drugalizer LE5 Drug Tester System2019-10-04
OMEGA LABORATORIES, INC.
Alcolizer LE5 Alcohol Tester2019-10-04
OMEGA LABORATORIES, INC.
Alcolizer LE5 Alcohol Tester2019-10-04
Omega Laboratories, Inc.
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) And -3, 4-methylenedioxymethamphetamine (MDMA)2015-07-28
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE2015-01-08
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES2013-11-13
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE2013-06-25
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)2012-12-05
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES2012-01-23
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES2011-12-13
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)2011-08-16
OMEGA LABORATORIES, INC.
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE2010-07-12
OMEGA LABORATORIES, INC.
HAIR COLLECTION KIT2005-11-16

Related Finance Registrations
NCAGE Code15205OMEGA LABORATORIES INC
NCAGE Code15305OMEGA LABORATORIES INC
NCAGE Code4YK11OMEGA LABORATORIES, INC.
NCAGE Code58105OMEGA LABORATORIES INC
NCAGE Code9R520OMEGA LABORATORIES INC
NCAGE Code1WPE0OMEGA LABORATORIES INC.!DBA OMEGA ENVIRONMENTAL SERVICES
CAGE Code15205OMEGA LABORATORIES INC
CAGE Code15305OMEGA LABORATORIES INC
CAGE Code1WPE0OMEGA LABORATORIES INC. OMEGA ENVIRONMENTAL SERVICES
CAGE Code4YK11OMEGA LABORATORIES, INC.
CAGE Code58105OMEGA LABORATORIES INC
CAGE Code9R520OMEGA LABORATORIES INC
S.A.M. Registration1WPE0 [796871796]OMEGA LABORATORIES INC. OMEGA ENVIRONMENTAL SERVICES
S.A.M. Registration4YK11 [5045559]OMEGA LABORATORIES, INC.
DUNS001038868Omega Laboratories Inc
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