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Abbott Architect Folate

by Abbott Laboratories 510(k)

Active United States

510(k) K023397

Overview

The Abbott Architect Folate is a radioimmunoassay device for measuring folic acid levels. It is classified as a Class II medical device under the Clinical Chemistry specialty.

The device received FDA 510(k) clearance (K023397) on December 16, 2002, as substantially equivalent to a predicate device. It is manufactured by Abbott Laboratories in Abbott Park, Illinois, and is intended for use in clinical laboratory settings.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023397 Date16 Dec 2002ClearedStatusActive

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

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0362-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K023397, on the same 510(k)
    • Terminated Z-0364-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K023397, on the same 510(k)
    • Terminated Z-0361-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K023397, on the same 510(k)
    • Terminated Z-0363-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K023397, on the same 510(k)

    The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

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 Abbott Architect Folate used for?

    The Abbott Architect Folate is a radioimmunoassay device designed to measure folic acid levels in clinical laboratory settings, as indicated in its device description and intended use.

  • How is the Abbott Architect Folate supplied or configured for use?

    The device is a radioimmunoassay system manufactured by Abbott Laboratories for use in clinical laboratories, with no additional supply details such as kit components or reagent formats provided in the data.

  • Is the Abbott Architect Folate a single-use or reusable device?

    The device data does not specify whether the Abbott Architect Folate is single-use or reusable; it is described as a radioimmunoassay device for clinical laboratory use, but no information on reusability or disposability is included.

  • What regulatory pathway was used for the Abbott Architect Folate?

    The Abbott Architect Folate received FDA 510(k) clearance under submission K023397 on December 16, 2002, as a substantially equivalent device to a predicate, classified as Class II under the Clinical Chemistry specialty.