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510(k) K946000

ABUSCREEN ONLINE(R) CALIBRATORS by Roche Diagnostic Systems, Inc. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1995
Date Received
December 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

Other clearances by Roche Diagnostic Systems, Inc.

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  • 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 DKJ

  • K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT (May 19, 2010)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K020794 — SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 11, 2002)
  • K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (February 15, 2002)
  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K981872 — SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (June 29, 1998)
  • K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (March 2, 1998)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K961131 — SALICYLATE ASSAY (April 29, 1996)
  • K951290 — AXSYM SALICYLATE (August 8, 1995)