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510(k) K946119

ROCHE-TDM ONLEIN(TM) CONTROLS by Roche Diagnostic Systems, Inc. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
December 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
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)

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  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)