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510(k) K903305

TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD by Technicon Instruments Corp. — Product Code KHS

K903305 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD". The FDA issued a decision of Substantially Equivalent on September 27, 1990. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1990
Date Received
July 24, 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 Technicon Instruments Corp.

  • K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (November 27, 1991)
  • K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (November 27, 1991)
  • K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (November 22, 1991)
  • K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (September 25, 1991)
  • K912413 — CHEM-LINK DATA BASE MANAGER (July 1, 1991)
  • K903824 — DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (September 27, 1990)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (September 27, 1990)
  • K903306 — TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (August 29, 1990)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K902243 — TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES (July 5, 1990)

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)
  • K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, (May 10, 2010)

FDA data resources