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510(k) K012656

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 by Bio-Rad — Product Code JJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
August 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (January 24, 2003)
  • K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (May 24, 2002)
  • K993723 — CARDIASURE CARDIAC MARKERS CONTROL (November 23, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (August 30, 1999)
  • K984437 — QUANTEX ASO-CRP-RP CONTROL II (February 2, 1999)
  • K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (December 9, 1998)