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510(k) K113435

ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT by Alfa Wassermann — Product Code KHS

K113435 is an FDA 510(k) premarket notification submitted by Alfa Wassermann for the device "ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT". The FDA issued a decision of Substantially Equivalent on July 2, 2012. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Alfa Wassermann has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2012
Date Received
November 21, 2011
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 Alfa Wassermann

  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)
  • K091413 — S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC00 (October 26, 2009)
  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (September 9, 2009)
  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K080073 — S-TEST CREATININE (CRE) (June 30, 2008)
  • K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-7 (April 17, 2007)

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)
  • 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