Folate Radioassay Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K801198 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Calbiochem-Behring Corp. →

• What is the Folate Radioassay Kit used for?

  The Folate Radioassay Kit is used for detecting acid, folic, and is classified as a Class II device with special controls.

• Is the Folate Radioassay Kit reusable?

  No, the Folate Radioassay Kit is a non-reusable device, and its storage and use are subject to the manufacturer's instructions.

• What is the regulatory status of the Folate Radioassay Kit?

  The Folate Radioassay Kit has been cleared by the FDA with a 510K clearance, with the decision date being July 21, 1980.

• How is the Folate Radioassay Kit supplied?

  The kit is supplied by Calbiochem-Behring Corp. and has a product code of CGN.