510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821000Substantially Equivalent

Enzymune-Test Digoxin

Icl Scientific, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821000 is the FDA 510(k) clearance record for ENZYMUNE-TEST DIGOXIN, a class II device, cleared for Icl Scientific on under FDA product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.). FDA records list 48 510(k) clearances for Icl Scientific, from to . As of , FDA records show no recalls naming K821000.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Icl Scientific 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DON

Trailing 12 months

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

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