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510(k) K961436

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) by Roche Diagnostic Systems, Inc. — Product Code DLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1996
Date Received
April 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
Submission Type

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  • 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 DLB

  • K955448 — EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (February 23, 1996)
  • K955814 — CEDIA DAU LSD ASSAY (February 9, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K891167 — COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (May 3, 1989)
  • K874270 — REVISED LABELING FOR LSD TEST KIT (November 13, 1987)
  • K860525 — ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (April 11, 1986)