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510(k) K140248

S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) by Hitachi Chemical Diagnostics, Inc. — Product Code KHS

K140248 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)". The FDA issued a decision of Substantially Equivalent on March 11, 2014. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2014
Date Received
January 30, 2014
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 Hitachi Chemical Diagnostics, Inc.

  • K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle (October 18, 2021)
  • K182793 — AP3600 Automated Instrument (March 19, 2019)
  • K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (October 28, 2013)
  • K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (August 9, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (June 7, 2013)
  • K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (May 2, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K112910 — AP 72OS SEMI-AUTOMATED INSTRUMENT (December 20, 2012)

Other clearances for product code KHS

  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • 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)
  • K093611 — VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATO (April 15, 2010)

FDA data resources