Home / 510(k) Clearances / K033731

510(k) K033731

AXSYM CORTISOL ASSAY by Fujirebio Diagnostics,Inc. — Product Code JFT

K033731 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "AXSYM CORTISOL ASSAY". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

Other clearances by Fujirebio Diagnostics,Inc.

  • K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 (December 16, 2025)
  • K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (May 16, 2025)
  • DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40) (May 4, 2022)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)

Other clearances for product code JFT

  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K192788 — ADVIA Centaur Cortisol (COR) (November 25, 2019)
  • K152227 — Elecsys Cortisol II, Cortisol II CalSet (April 27, 2016)
  • K142723 — ADVIA Centaur Cortisol (COR) Assy (March 31, 2015)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K021218 — ELECSYS CORTISOL TEST SYSTEM (September 9, 2002)
  • K962559 — ACS CORTISOL IMMUNOASSAY (November 5, 1996)
  • K954591 — AIA-PACK CORT ASSAY (December 15, 1995)
  • K934317 — CIDBA CORNING ACS CORTISOL IMMUNOASSAY (May 13, 1994)
  • K930732 — DELFIA CORTISOL KIT (July 27, 1993)

FDA data resources