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510(k) K091153

SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 by Beckman Coulter, Inc. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2009
Date Received
April 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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  • K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (October 24, 2012)
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  • K111960 — ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE (November 18, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)
  • K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, (May 10, 2010)