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510(k) K930732

DELFIA CORTISOL KIT by Wallac OY — Product Code JFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
February 11, 1993
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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  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)

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)
  • 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)