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510(k) K110035

INDIKO by Thermofisher Scientific OY — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2011
Date Received
January 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (February 28, 2008)
  • K070824 — CREATININE (ENZYMATIC) (December 3, 2007)
  • K071340 — CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (October 5, 2007)
  • K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (October 3, 2007)

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  • K130276 — DIMENSION EXL WITH LM SYSTEM (March 22, 2013)
  • K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGEN (May 17, 2012)
  • K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM (November 22, 2011)
  • K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER (May 8, 2008)
  • K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (November 13, 2006)
  • K051087 — DIMENSION VISTA INTEGRATED SYSTEM (July 11, 2005)