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510(k) K880794

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL by Trace America, Inc. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
February 26, 1988
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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  • K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (May 27, 1997)
  • K962723 — TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (March 13, 1997)

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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)
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