ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech …
FDA 510(k)Class II (US FDA 510(k))
by Elitechgroup
Identifiers
- 510(k) Number
- K151552 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, and ELITech Clinical Systems ELITROL II are multi-parametric calibrators and quality control sera. The ELICAL 2 serves as a multi-parametric calibrator, while the ELITROL I and ELITROL II serve as two-level quality control sera. These products are intended for use in clinical laboratories to support the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
The device is supplied as a multi-parametric calibrator and two-level quality control sera. The ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use. The device is regulated under the FDA 510(k) pathway, with a decision of Substantially Equivalent. The product code is JIX, and the device class is 2.
Frequently asked questions
What is the purpose of the ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II?
These products are multi-parametric calibrators and quality control sera. The ELICAL 2 serves as a calibrator, while the ELITROL I and ELITROL II serve as two-level quality control sera. They are intended for use in clinical laboratories to support the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
How is the device supplied?
The device is supplied as a multi-parametric calibrator and two-level quality control sera. The ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use.
What is the regulatory status of these products?
The device is regulated under the FDA 510(k) pathway, with a decision of Substantially Equivalent. The product code is JIX, and the device class is 2.
What is the difference between the ELITROL I and ELITROL II?
Both the ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use. The ELITROL I and ELITROL II serve as two-level quality control sera, while the ELICAL 2 serves as a multi-parametric calibrator.
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: ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I ..., ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL ..., Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I ..., ELITROL I & II Control Sera Overview | PDF | Hepatitis C | Clinical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151552 | Class II | Active |
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Manufacturer
- Manufacturer
- Elitechgroup
Sources (1)
- FDA 510(k) K151552 24 fields · synced Sep 21, 2026