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510(k) K911652

MIRCOLINE SCREEN FOR COCAINE by Drug Screening Systems, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
April 12, 1991
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 Drug Screening Systems, Inc.

  • K945829 — MICROLINE SCREEN FOR BENZODIAZEPINE (January 25, 1995)
  • K935052 — MICROLINE SCREEN FOR AMPHETAMINE (September 16, 1994)
  • K933480 — MICROLINE SCREEN FOR BARBITURATES (October 29, 1993)
  • K921651 — MICROLINE SCREEN FOR PHENCYCLIDINE (July 8, 1992)
  • K914915 — MICROLINE SCREEN FOR CANNABINOID (January 22, 1992)
  • K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE (April 5, 1991)
  • K905491 — MICROLINE SCREEN FOR OPIATES (March 13, 1991)

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)