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510(k) K152227

Elecsys Cortisol II, Cortisol II CalSet by Roche Diagnostics — Product Code JFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2016
Date Received
August 7, 2015
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

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Other clearances for product code JFT

  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K192788 — ADVIA Centaur Cortisol (COR) (November 25, 2019)
  • K142723 — ADVIA Centaur Cortisol (COR) Assy (March 31, 2015)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K033731 — AXSYM CORTISOL ASSAY (February 20, 2004)
  • 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)