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510(k) K010868

PSYCHEMEDICS RIA COCAINE ASSAY by Psychemedics Corp. — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2001
Date Received
March 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cocaine Metabolite
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)
  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K111929 — PSYCHEMEDICS CANNABINOIDS EIA (May 1, 2012)
  • K111926 — PSYCHEMEDICS OPIATES 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)

Other clearances for product code KLN

  • K913867 — URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (September 19, 1991)
  • K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (September 10, 1991)
  • K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (July 26, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910044 — MILENIA COCAINE METABOLITE (February 13, 1991)
  • K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (January 15, 1991)
  • K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (November 28, 1990)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)
  • K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (June 16, 1987)