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510(k) K904007

BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 by Amresco, Inc. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1990
Date Received
August 29, 1990
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

Other clearances by Amresco, Inc.

  • K905618 — GGT REAGENT (February 26, 1991)
  • K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (January 17, 1991)
  • K905684 — ALKALINE PHOSPHATASE (December 28, 1990)
  • K905544 — MAGNESIUM REAGENT (December 27, 1990)
  • K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (December 11, 1990)
  • K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (December 11, 1990)
  • K905096 — GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (November 28, 1990)
  • K904381 — DIAZO COLORIMENTRY DIRECT BILIRUBIN (October 12, 1990)
  • K903775 — CREATINE PHOSPHOKINASE (October 4, 1990)
  • K903829 — AST REAGENT (September 25, 1990)

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  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)
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  • K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (October 24, 2012)
  • K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILI (July 2, 2012)
  • 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)