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Technicon Ra System Thyroxine T4 Method

by Technicon Instruments Corp. 510(k)

Active United States

510(k) K894575

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894575 Date4 Oct 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CDX
Device Class
Class II
Regulation
21 CFR Part 862.1700
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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