510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K854638Substantially Equivalent

Cedia Digoxin Assay

Microgenics Corporation, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854638 is the FDA 510(k) clearance record for CEDIA DIGOXIN ASSAY, a class II device, cleared for Microgenics Corp. on under FDA product code KXT (Enzyme Immunoassay, Digoxin). FDA records list 128 510(k) clearances for Microgenics Corp., from to . As of , FDA records show no recalls naming K854638.

Clearance record

Decision date
Received
(126 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corp. 2380a Bisso Ln., Concord CA
Third party review
No

Clearances, product code KXT

Trailing 12 months

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

FDA records show no clearances under product code KXT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXT, 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