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510(k) K860049

DETERMINATION OF QUINIDINE by Clinical Data, Inc. — Product Code LBZ

K860049 is an FDA 510(k) premarket notification submitted by Clinical Data, Inc. for the device "DETERMINATION OF QUINIDINE". The FDA issued a decision of Substantially Equivalent on January 22, 1986. The device falls under product code LBZ (Enzyme Immunoassay, Quinidine), a Class II device regulated under 21 CFR 862.3320. Clinical Data, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1986
Date Received
January 6, 1986
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

Other clearances by Clinical Data, Inc.

  • K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55 (December 20, 2007)
  • K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (February 9, 2006)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)

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)

FDA data resources