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510(k) K880674

MICROMEDIC CRACKPOT RIA KIT by Icn Micromedic Systems — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
February 19, 1988
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 Icn Micromedic Systems

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  • K883746 — MICROMEDIC FERRITIN IRMA KIT (October 27, 1988)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)

Other clearances for product code KLN

  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)
  • 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)
  • K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (June 16, 1987)