EasyStat 300
FDA 510(k) K211559 · Medica Corporation
510(k) numberK211559
Submission
- Device name
- EasyStat 300
- Applicant
- Medica Corporation
Bedford, MA, US - Received
- May 20, 2021
- Decision date
- January 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| 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 |
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Questions and answers
When was EasyStat 300 cleared by the FDA?
EasyStat 300 (K211559) received a 510(k) decision of Substantially Equivalent on January 27, 2023, 617 days after the submission was received.
What is the product code of K211559?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.