510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772306Substantially Equivalent

125I Digoxin Test Set

Wien Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772306 is the FDA 510(k) clearance record for 125I DIGOXIN TEST SET, a class II device, cleared for Wien Laboratories, Inc. on under FDA product code DPB (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.). FDA records list 13 510(k) clearances for Wien Laboratories, Inc., from to . As of , FDA records show no recalls naming K772306.

Clearance record

Decision date
Received
(7 days to decision)
Product code
DPB Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Wien Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DPB

Trailing 12 months

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

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