Home / 510(k) Clearances / K974551

510(k) K974551

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY by Sealite Sciences, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
December 4, 1997
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 Sealite Sciences, Inc.

  • K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (September 25, 1997)
  • K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (June 24, 1997)
  • K970483 — AQUALITE INTACT PTH (April 14, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (February 14, 1997)
  • K964925 — SEALITE SCIENCES, INC. AQUALITE LH (January 22, 1997)
  • K942661 — AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (January 17, 1995)
  • K943437 — AQUALITE FSH (December 28, 1994)
  • K943188 — SEALITE SCIENCE, INC. AQUALITE(R) LH (October 20, 1994)
  • K941983 — SEALITE SCIENCES INC. (August 18, 1994)

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)