510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803045Substantially Equivalent

Immu-Trace Digoxin (125I) Radioimmun.

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

K803045 is the FDA 510(k) clearance record for IMMU-TRACE DIGOXIN (125I) RADIOIMMUN., a class II device, cleared for American Dade on under FDA product code DOG (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K803045.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DOG Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
American Dade 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DOG

Trailing 12 months

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

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