Home / 510(k) Clearances / K894091

510(k) K894091

AMERLEX-MAB FT4 KIT by Amersham Corp. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
June 9, 1989
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 Amersham Corp.

  • K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (February 18, 1992)
  • K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (July 22, 1991)
  • K912766 — AMERLITE CK-MB ASSAY (July 17, 1991)
  • K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (November 2, 1990)
  • K902760 — AMERSHAM TSH CONTROL SERA (July 27, 1990)
  • K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCES (July 9, 1990)
  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

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)
  • K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (January 27, 2014)