510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780207Substantially Equivalent

Liquisol Digoxin Ria Test Kit

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

K780207 is the FDA 510(k) clearance record for LIQUISOL DIGOXIN RIA TEST KIT, a class II device, cleared for Damon Corp. on under FDA product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.). FDA records list 10 510(k) clearances for Damon Corp., from to . As of , FDA records show no recalls naming K780207.

Clearance record

Decision date
Received
(16 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
Damon Corp. 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