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510(k) K100289

ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 by Siemens Healthcare Diagnostics — Product Code KHS

K100289 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781". The FDA issued a decision of Substantially Equivalent on May 10, 2010. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2010
Date Received
February 2, 2010
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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Other clearances for product code KHS

  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (March 11, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)
  • K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA (May 2, 2013)
  • 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)
  • K093611 — VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATO (April 15, 2010)

FDA data resources