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510(k) K131244

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET by Roche Diagnostics — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2014
Date Received
May 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

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Other clearances for product code CEC

  • K240273 — Access Free T4 (March 6, 2024)
  • K220456 — Elecsys FT4 IV (April 7, 2023)
  • K182423 — MAGLUMI 2000 FT4 (October 4, 2018)
  • K181233 — Elecsys FT4 III (September 18, 2018)
  • K173122 — Abbott Architect Free T4 (October 27, 2017)
  • K152422 — FREND™ Free T4 Test System (February 17, 2016)
  • K132058 — VIDAS FT4 (June 8, 2015)
  • K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYR (November 26, 2014)
  • K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYRO (November 26, 2014)
  • K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (September 13, 2013)