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510(k) K850808

COBAS FP REAGENTS FOR QUINIDINE by Roche Diagnostic Systems, Inc. — Product Code LBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1985
Date Received
February 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Quinidine
Device Class
Class II
Regulation Number
862.3320
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)
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  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
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Other clearances for product code LBZ

  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K032332 — ROCHE ONLINE TDM QUINIDINE (January 12, 2004)
  • K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (June 12, 2001)
  • K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (December 24, 1996)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEM (April 4, 1996)
  • K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (July 6, 1994)
  • K922913 — EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (August 24, 1992)
  • K904990 — EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (February 4, 1991)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)