510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811212Substantially Equivalent

Digoxin (Ria) Kit

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

K811212 is the FDA 510(k) clearance record for DIGOXIN (RIA) KIT, a class II device, cleared for Immuno Assay Corp. on under FDA product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.). FDA records list 10 510(k) clearances for Immuno Assay Corp., from to . As of , FDA records show no recalls naming K811212.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Immuno Assay Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DNL

Trailing 12 months

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

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