FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EasyStat 300
K Number: K220396
·
Decision Sep 26, 2023
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
88
Applicant Total
7
Review Days
592
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Basic Information
- Device Name
- EasyStat 300
- K Number
- K220396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medica Corporation
- Date Received
- February 11, 2022
- Decision Date
- September 26, 2023
- Product Code
- CEM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Medica Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K220328 | EasyStat 300 | Jul 26, 2024 | Substantially Equivalent |
| K211559 | EasyStat 300 | Jan 27, 2023 | Substantially Equivalent |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Dec 1, 2016 | Substantially Equivalent |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | May 13, 2014 | Substantially Equivalent |
| K123586 | EASYRA CREATININE REAGENT | May 15, 2013 | Substantially Equivalent |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT | Jul 12, 2011 | Substantially Equivalent |