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510(k) K062204

ARCHITECT CORTISOL ASSAY by Seradyn, Inc. — Product Code JFT

K062204 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "ARCHITECT CORTISOL ASSAY". The FDA issued a decision of Substantially Equivalent on September 22, 2006. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
August 1, 2006
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 Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (January 12, 2007)
  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)
  • K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (February 9, 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)
  • 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)

FDA data resources