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Omega Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K142855Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphJuly 28, 2015
K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONEJanuary 8, 2015
K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESNovember 13, 2013
K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEJune 25, 2013
K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)December 5, 2012
K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESJanuary 23, 2012
K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESDecember 13, 2011
K101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINEAugust 16, 2011
K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINEJuly 12, 2010