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510(k) K931031

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT by Biomerieux Vitek, Inc. — Product Code JFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
March 1, 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

Other clearances by Biomerieux Vitek, Inc.

  • K973819 — VIDAS D-DIMER (DD) ASSAY (March 10, 1998)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY (April 8, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)

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)