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125 I Folate Solid Phase Radioassay

by Abbott Laboratories 510(k)

Active United States

510(k) K792167

Overview

The 125 I Folate Solid Phase Radioassay is a clinical chemistry device used for measuring folate levels through radioimmunoassay techniques. It is designed to provide accurate quantification of folate in patient samples for diagnostic purposes.

This device is supplied by Abbott Laboratories and is classified under product code CGN with FDA 510(k) clearance K792167, granted on November 13, 1979. It is regulated under 862.1295 and is intended for use in clinical chemistry laboratories. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792167 Date13 Nov 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
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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Questions

  • What is the 125 I Folate Solid Phase Radioassay used for?

    The 125 I Folate Solid Phase Radioassay is used for measuring folate levels in patient samples for diagnostic purposes in clinical chemistry laboratories.

  • Is the 125 I Folate Solid Phase Radioassay single-use or reusable?

    The device is not specified as single-use or reusable.

  • What are the storage conditions for the 125 I Folate Solid Phase Radioassay?

    No information regarding storage conditions is provided for the device.

  • What is the regulatory classification of the 125 I Folate Solid Phase Radioassay?

    The device is regulated under 862.1295 and has FDA 510(k) clearance K792167.