EasyRA Clinical Chemistry Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K070057 FDA 510(k)
- FDA Product Code
- CGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyRA Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer designed to accommodate the diverse needs of small laboratories. It provides high-quality clinical chemistry analysis with low operating costs.
This analyzer is supplied for use in laboratory settings and is not specified as single-use or reusable. It is MRI safe and has received FDA 510(k) clearance with the product code CGA. The device is manufactured by Medica Corp. and is authorized for clinical chemistry analysis.
Frequently asked questions
What is the EasyRA Clinical Chemistry Analyzer designed for?
The EasyRA Clinical Chemistry Analyzer is designed for high-quality clinical chemistry analysis in small laboratory settings, accommodating diverse laboratory needs with low operating costs.
Is the EasyRA analyzer single-use or reusable?
The EasyRA analyzer is supplied for use in laboratory settings and is not specified as single-use or reusable, indicating it can be used multiple times in a laboratory environment.
What regulatory clearance has the EasyRA analyzer received?
The EasyRA analyzer has received FDA 510(k) clearance with the product code CGA, making it substantially equivalent to other devices in this category.
Is the EasyRA analyzer MRI safe?
Yes, the EasyRA analyzer is MRI safe, meaning it can be used in environments with MRI equipment without interfering with the imaging process.
Who manufactures the EasyRA Clinical Chemistry Analyzer?
The EasyRA Clinical Chemistry Analyzer is manufactured by Medica Corp., with their headquarters located at 5 Oak Park Dr., Bedford, MA 01730, USA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clinical chemistry analyzer - EasyRA - Medica Corporation, Clinical chemistry analysis - Fully automated chemistry analyzer, Medica EasyRA Clinical Chemistry Analyzer - medical-xprt.com, Medica EasyRA Clinical Chemistry Analyzer: The Complete STAT Solution
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070057 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K070057 24 fields · synced Sep 19, 2026