Home / 510(k) Clearances / K152422

510(k) K152422

FREND™ Free T4 Test System by Nanoentek USA, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2016
Date Received
August 26, 2015
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

Other clearances by Nanoentek USA, Inc.

  • K162378 — FREND PSA PLUS (reagent cartridge) (May 17, 2017)
  • K162754 — FREND Vitamin D Test System (January 12, 2017)
  • K153577 — FREND Testosterone Test System (October 14, 2016)
  • K131928 — FREND TSH (REAGENT CARTRIDGE) (March 14, 2014)

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)
  • 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)
  • K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (January 27, 2014)
  • K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (September 13, 2013)