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510(k) K000926

EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER by Medica Corp. — Product Code CGZ

K000926 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on May 15, 2000. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Medica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2000
Date Received
March 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Medica Corp.

  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)
  • K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (May 14, 2012)
  • K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (December 6, 2011)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K112788 — EASTLYTE NA/K/CA/PH (October 20, 2011)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (May 20, 2011)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)
  • K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBO (January 14, 2011)

Other clearances for product code CGZ

  • K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR (October 30, 2018)
  • K170320 — Alinity c ICT Sample Diluent (October 24, 2017)
  • K162020 — VITROS Chemistry Products Cl- Slides (December 16, 2016)
  • K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR (August 21, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALY (September 4, 2007)
  • K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (February 16, 2006)
  • K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (September 29, 2005)
  • K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (February 4, 2002)
  • K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (December 18, 2001)

FDA data resources