510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863422Substantially Equivalent

Delfia(tm) Cortisol Kit

Lkb Instruments, Inc., Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863422 is the FDA 510(k) clearance record for DELFIA(TM) CORTISOL KIT, a class II device, cleared for Lkb Instruments, Inc. on under FDA product code JFT (Fluorometric, Cortisol). FDA records list 52 510(k) clearances for Lkb Instruments, Inc., from to . As of , FDA records show no recalls naming K863422.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JFT Fluorometric, Cortisol
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Lkb Instruments, Inc. 9319 Gaither Rd., Gaithersburg MD
Third party review
No

Clearances, product code JFT

Trailing 12 months

FDA records hold no clearances under product code JFT in the trailing twelve months.

FDA records show no clearances under product code JFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260