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510(k) K964212

QUINIDINE ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc. — Product Code LBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
October 22, 1996
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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Other clearances for product code LBZ

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  • K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (December 24, 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)
  • K892208 — INNOFLUOR(TM) QUINIDINE REAGENT SET (June 9, 1989)