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510(k) K111925

PSYCHEMEDICS COCAINE EIA by Psychemedics Corp. — Product Code JXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2012
Date Received
July 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Psychemedics Corp.

  • K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (May 2, 2013)
  • K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (February 8, 2013)
  • K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA (May 1, 2012)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K111926 — PSYCHEMEDICS OPIATES EIA (May 1, 2012)
  • K111929 — PSYCHEMEDICS CANNABINOIDS EIA (May 1, 2012)
  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (February 11, 2002)
  • K011185 — PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (January 24, 2002)
  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)

Other clearances for product code JXO

  • K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (June 25, 2021)
  • K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (August 24, 1992)
  • K921140 — STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (August 20, 1992)
  • K915785 — STC DIAGNOSTICS BENZOYLECGONINE EIA (March 11, 1992)
  • K913737 — IL TEST(TM) COCAINE (December 3, 1991)