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510(k) K062929

QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA by Quest Diagnostics, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2006
Date Received
September 28, 2006
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 Quest Diagnostics, Inc.

  • K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (June 25, 2008)
  • K051161 — QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (November 22, 2005)
  • K042726 — QUEST DIAGNOSTICS HAIRCHECK-DT (PCP (July 28, 2005)
  • K042725 — QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (July 6, 2005)
  • K040257 — QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (June 14, 2004)
  • K023626 — AML HAIRCHECK-DT (COCAINE) (September 29, 2003)

Other clearances for product code DIO

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K211973 — DRI Cocaine Metabolite Assay (September 24, 2021)
  • 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)