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510(k) K123799

PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR by Psychemedics Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2013
Date Received
December 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Psychemedics Corp.

  • K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (May 2, 2013)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K111926 — PSYCHEMEDICS OPIATES EIA (May 1, 2012)
  • K111927 — PSYCHEMEDICS METHAMPHETAMINE 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)

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