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510(k) K946146

CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION by Clinical Controls, Inc. — Product Code JJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1995
Date Received
December 16, 1994
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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  • K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2 (April 24, 1996)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 1995)
  • K946049 — LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946048 — LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (February 10, 1995)

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  • K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (March 21, 2003)
  • 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)
  • K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (September 6, 2001)
  • 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)