EasyStat 300
FDA 510(k) K220328 · Medica Corporation
510(k) numberK220328
Submission
- Device name
- EasyStat 300
- Applicant
- Medica Corporation
Bedford, MA, US - Received
- February 4, 2022
- Decision date
- July 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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More from Abbott Point of Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220396 | EasyStat 300CEM · Traditional | 09/26/2023SE |
| K211559 | EasyStat 300CHL · Traditional | 01/27/2023SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | 12/01/2016SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | 05/13/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | 05/15/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | 03/01/2013SE |
| K120497 | Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialLCP · Traditional | 05/14/2012SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | 12/06/2011SE |
| K111005 | Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional | 11/15/2011SE |
| K112788 | Eastlyte Na/K/Ca/PhCEM · Special | 10/20/2011SE |
Questions and answers
When was EasyStat 300 cleared by the FDA?
EasyStat 300 (K220328) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 903 days after the submission was received.
What is the product code of K220328?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.