Home / 510(k) Clearances / K220328

510(k) K220328

EasyStat 300 by Medica Corporation — Product Code CGA

K220328 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 July 26, 2024. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Medica Corporation has at least 6 other 510(k) clearances on record.

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

  • K220396 — EasyStat 300 (September 26, 2023)
  • 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 CGA

  • K252488 — ABL90 FLEX PLUS System (May 1, 2026)
  • K210933 — YSI 2900C Biochemistry Analyzer (September 30, 2024)
  • K223179 — Cholestech LDX ™ System (September 20, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)
  • K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)

FDA data resources