Radias Neonatal T4 Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K951321 FDA 510(k)
- FDA Product Code
- KLI 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 Radias Neonatal T4 Enzyme Immunoassay is a Class II medical device classified as an Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine. This device is designed for the quantitative determination of total thyroxine (T4) levels in neonatal specimens.
The device is manufactured by Bio-Rad and is supplied as a single-use or reusable product depending on the specific configuration. It is regulated under FDA 510(k) clearance with product code KLI and regulation number 862.1700, having received a 'Substantially Equivalent' decision on August 24, 1995.
Frequently asked questions
What is the Radias Neonatal T4 Enzyme Immunoassay used for?
The Radias Neonatal T4 Enzyme Immunoassay is designed for the quantitative determination of total thyroxine (T4) levels in neonatal specimens, aiding in the assessment of thyroid function in newborns.
Is the Radias Neonatal T4 Enzyme Immunoassay single-use or reusable?
The device is supplied as either a single-use or reusable product depending on the specific configuration selected by the user.
What regulatory status does the Radias Neonatal T4 Enzyme Immunoassay have?
The device is regulated under FDA 510(k) clearance with product code KLI and regulation number 862.1700, having received a 'Substantially Equivalent' decision on August 24, 1995.
What is the classification of the Radias Neonatal T4 Enzyme Immunoassay?
This is a Class II medical device classified as an Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine, manufactured by Bio-Rad for clinical chemistry applications.
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: K951321 FDA 510(k) - RADIAS NEONATAL T4 ENZYME IMMUNOASSAY, RADIAS NEONATAL T4 ENZYME IMMUNOASSAY - Innolitics, Radias Neonatal T4 Enzyme Immunoassay 510 (k) K951321 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951321 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K951321 24 fields · synced Sep 25, 2026