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510(k) K220396

EasyStat 300 by Medica Corporation — Product Code CEM

K220396 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EasyStat 300". The FDA issued a decision of Substantially Equivalent on September 26, 2023. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Medica Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2023
Date Received
February 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Medica Corporation

  • K220328 — EasyStat 300 (July 26, 2024)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K152327 — EasyLyte Na/K/Cl/Ca Analyzer (December 1, 2016)
  • K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CR (May 13, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)

Other clearances for product code CEM

  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K241037 — ABL90 FLEX PLUS System (January 14, 2025)
  • K230890 — ISE Electrodes (September 8, 2023)
  • K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (October 1, 2020)
  • K121012 — FLEXLAB 3.6, ACCELERATOR A3600 (August 31, 2012)
  • K121040 — SMARTLYTE ELECTROLYTE ANALYZER (August 30, 2012)
  • K112995 — GEM PREMIER 4000 (May 3, 2012)
  • K110520 — BIOLIS 12I (March 23, 2012)
  • K112412 — AU5800(R) CHEMISTRY ANALYZER (December 23, 2011)
  • K112408 — POLY-CHEM 90 ISE MODULE (November 4, 2011)

FDA data resources