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510(k) K131128

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES by Omega Laboratories, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2013
Date Received
April 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by Omega Laboratories, Inc.

  • K142855 — Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-me (July 28, 2015)
  • K140671 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCOD (January 8, 2015)
  • 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)
  • K101973 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENE (August 16, 2011)
  • K101059 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (July 12, 2010)

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  • K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (March 12, 2020)
  • K181499 — DRI Cocaine Metabolite Assay (July 6, 2018)
  • K170293 — Emit II Plus Cocaine Metabolite Assay (October 25, 2017)
  • K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (August 15, 2017)
  • K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (June 2, 2017)
  • K152232 — Quest Diagnostics HairCheck-DT (Cocaine) (November 18, 2016)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)