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Radias Red Cell Folate Immunoasay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K944212

by Bio-Rad

Identifiers

510(k) Number
K944212 FDA 510(k)
FDA Product Code
CGN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1295 FDA 510(k)
Regulation Number
862.1295 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Radias Red Cell Folate Immunoassay is a radioimmunoassay device used for the quantitative determination of folic acid. It is classified as a clinical chemistry device under product code CGN.

This device is regulated under FDA 510(k) number K944212 and is classified as a Class II device. It is subject to regulation number 862.1295 and received a substantially equivalent decision on February 3, 1995.

Frequently asked questions

What is the primary function of the Radias Red Cell Folate Immunoassay?

This device is a radioimmunoassay used for the quantitative determination of folic acid. It is categorized as a clinical chemistry device under product code CGN.

How is this device regulated in the United States?

The Radias Red Cell Folate Immunoassay is classified as a Class II device under regulation number 862.1295. It received a substantially equivalent decision from the FDA on February 3, 1995, under 510(k) number K944212.

Who is the manufacturer of this immunoassay device?

The device is manufactured by Bio-Rad, located in Hercules, California.

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: K944212 - RADIAS RED CELL FOLATE IMMUNOASAY | FDA 510 (k), Radias Red Cell Folate Immunoasay 510(k) K944212 - FDA.report, Radias Red Cell Folate Immunoasay 510(k) K944212 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K944212 24 fields · synced Sep 26, 2026