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510(k) K130811

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE by Psychemedics Corp. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2013
Date Received
March 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Psychemedics Corp.

  • K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (February 8, 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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