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510(k) K981388

MICRO-STRIP FOR COCAINE METABOLITES by Microdiagnostics, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1998
Date Received
April 16, 1998
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 Microdiagnostics, Inc.

  • K011952 — DRUGS OF ABUSE MULTI-TEST STRIP (October 25, 2001)
  • K991505 — MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (August 5, 1999)
  • K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES (August 5, 1999)
  • K974611 — MICRO-STRIP FOR AMPHETAMINE METABOLITES (March 20, 1998)
  • K973761 — MICRO-STRIP FOR OPIATE METABOLITES (December 24, 1997)
  • K932304 — MICRO EIA FOR AMPHETAMINE METABOLITES (December 7, 1993)
  • K923468 — MICRO EIA FOR OPIATE METABOLITES (September 15, 1992)
  • K914533 — MICRO EIA FOR COCAINE METABOLITES (December 10, 1991)
  • K914490 — MICRO EIA FOR MARIJUANA METABOLITES (November 29, 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)