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510(k) K905730

ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) by Roche Diagnostic Systems, Inc. — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1991
Date Received
December 24, 1990
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 Roche Diagnostic Systems, Inc.

  • K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (May 3, 1999)
  • K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (February 11, 1999)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

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)
  • 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)