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510(k) K863422

DELFIA(TM) CORTISOL KIT by Lkb Instruments, Inc. — Product Code JFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1986
Date Received
September 4, 1986
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 Lkb Instruments, Inc.

  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872955 — DELFIA(TM) FERRITIN KIT (August 21, 1987)
  • K871303 — DELFIA(TM) THYROXINE (T4) KIT (June 17, 1987)
  • K871599 — DELFIA(TM) HIGE KIT (June 12, 1987)
  • K871644 — DELFIA (TM) HTSH KIT (May 12, 1987)
  • K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (February 2, 1987)
  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K861195 — DELFIA DIGOXIN (July 11, 1986)
  • K862044 — DELFIA (TM) HCG KIT (July 11, 1986)

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)