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510(k) K220328

EasyStat 300 by Medica Corporation — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
February 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Medica Corporation

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  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)

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