ARCHITECT CORTISOL ASSAY— 510(k) K062204

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K062204 for ARCHITECT CORTISOL ASSAY, Substantially Equivalent on 2006-09-22. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code JFT
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2006-08-01
Decision date: 2006-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFT

K242505 — Elecsys Cortisol III2025-07-17
K192788 — ADVIA Centaur Cortisol (COR)2019-11-25
K152227 — Elecsys Cortisol II, Cortisol II CalSet2016-04-27
K142723 — ADVIA Centaur Cortisol (COR) Assy2015-03-31
K033731 — AXSYM CORTISOL ASSAY2004-02-20

More clearances from Seradyn, Inc.

K070645 — SERADYN QMS TOPIRAMATE2007-05-17
K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS2007-01-12
K060998 — QMS TOBRAMYCIN2006-07-21
K060709 — MULTIGENT GENTAMICIN2006-06-15
K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS2005-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.