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EMIT AAII Thyroxine Calibrators

by Syva Co. 510(k)

Active United States

510(k) K801287

Overview

EMIT AAII Thyroxine Calibrators are a primary calibrator device used in clinical chemistry for the measurement of thyroxine levels. The device is substantially equivalent to a legally marketed predicate and received FDA 510(k) clearance under K801287 on June 30, 1980.

The calibrators are supplied by Syva Co. and are intended for use in laboratory settings. They are classified as Class II medical devices with product code JIS and are regulated under 21 CFR 862.1150. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are included.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801287 Date30 Jun 1980ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIS
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EMIT AAII Thyroxine Calibrator used for?

    The EMIT AAII Thyroxine Calibrators are primary calibrator devices used in clinical chemistry laboratories for the measurement of thyroxine levels in patient samples.

  • How are these calibrators supplied and what is their regulatory classification?

    The calibrators are supplied by Syva Co. and are classified as Class II medical devices with product code JIS, regulated under 21 CFR 862.1150.

  • What is the regulatory status of these calibrators?

    The device received FDA 510(k) clearance under K801287 on June 30, 1980, and is substantially equivalent to a legally marketed predicate device.

  • Are these calibrators sterile, single-use, or reusable?

    The provided data does not specify whether the EMIT AAII Thyroxine Calibrators are sterile, single-use, or reusable.