Identifiers
- 510(k) Number
- K761272 FDA 510(k)
- FDA Product Code
- CDX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1700 FDA 510(k)
- Regulation Number
- 862.1700 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Centria T4 Ria is a radioimmunoassay device designed for the measurement of total thyroxine. It functions as a clinical chemistry diagnostic tool to assist in the assessment of thyroid function.
This device is regulated under FDA 510(k) number K761272 and is classified as a class 2 medical device. It is intended for use in clinical laboratory settings for the quantitative determination of total thyroxine in human serum.
Frequently asked questions
What is the primary clinical application of the Centria T4 RIA?
The Centria T4 RIA is designed for the quantitative determination of total thyroxine in human serum. It serves as a clinical chemistry diagnostic tool to assist healthcare professionals in the assessment of thyroid function.
In what environment is this device intended to be used?
This device is intended for use specifically within clinical laboratory settings. It is classified as a class 2 medical device and is designed to provide quantitative measurements for diagnostic purposes.
What is the regulatory status of the Centria T4 RIA?
The Centria T4 RIA is regulated under FDA 510(k) number K761272. It was cleared through the traditional 510(k) process and determined to be substantially equivalent to existing devices in the clinical chemistry specialty.
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: CENTRIA T4 RIA 510 (k) K761272 - FDA.report, FDA Browser - Cleared 510 (K) - CENTRIA T4 RIA (K761272), 510 (k) K761272 — CENTRIA T4 RIA — RegDataLab, CENTRIA T4 RIA TEST SET 510 (k) K790800 - FDA.report, Clinical Diagnostics, Inc. FDA 510 (k) Products (1977-1998)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K761272 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Diagnostics, Inc.
Sources (1)
- FDA 510(k) K761272 24 fields · synced Sep 26, 2026