510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922353Substantially Equivalent

Digoxin Coated Tube Ria

Monobind, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922353 is the FDA 510(k) clearance record for DIGOXIN COATED TUBE RIA, a class II device, cleared for Monobind on under FDA product code LCS (Radioimmunoassay, Digoxin (125-I)). FDA records list 23 510(k) clearances for Monobind, from to . As of , FDA records show no recalls naming K922353.

Clearance record

Decision date
Received
(97 days to decision)
Product code
LCS Radioimmunoassay, Digoxin (125-I)
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Monobind 729 W. 16th St., C-4, Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code LCS

Trailing 12 months

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

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