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510(k) K101973

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) by Omega Laboratories, Inc. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2011
Date Received
July 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Omega Laboratories, Inc.

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  • K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (November 13, 2013)
  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
  • K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (December 5, 2012)
  • K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (January 23, 2012)
  • K103161 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (December 13, 2011)
  • K101059 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (July 12, 2010)

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