FDA 510(k) Applications Submitted by OMEGA LABORATORIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140671 |
03/18/2014 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE |
OMEGA LABORATORIES, INC. |
| K101059 |
04/15/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
| K101973 |
07/13/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) |
OMEGA LABORATORIES, INC. |
| K122759 |
09/10/2012 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) |
OMEGA LABORATORIES, INC. |
| K112808 |
09/27/2011 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
OMEGA LABORATORIES, INC. |
| K131128 |
04/23/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
OMEGA LABORATORIES, INC. |
| K103161 |
10/27/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES |
OMEGA LABORATORIES, INC. |
| K131181 |
04/25/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
| K142855 |
09/30/2014 |
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) |
Omega Laboratories, Inc. |
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