510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K924504Substantially Equivalent

Fast Digoxin Test System

Diatron Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924504 is the FDA 510(k) clearance record for FAST DIGOXIN TEST SYSTEM, a class II device, cleared for Diatron Corp. on under FDA product code KXT (Enzyme Immunoassay, Digoxin). FDA records list one 510(k) clearance for Diatron Corp. As of , FDA records show no recalls naming K924504.

Clearance record

Decision date
Received
(131 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diatron Corp. 7340 A Trade St., San Diego CA
510(k) summary
Summary
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