510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822344Substantially Equivalent

Antimicrobial Removal Device (Ard)

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

K822344 is the FDA 510(k) clearance record for ANTIMICROBIAL REMOVAL DEVICE (ARD), a class I device, cleared for Marion Laboratories, Inc. on under FDA product code LJF (Device, Antimicrobial Drug Removal). FDA records list 38 510(k) clearances for Marion Laboratories, Inc., from to . As of , FDA records show no recalls naming K822344.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LJF Device, Antimicrobial Drug Removal
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
Marion Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LJF

Trailing 12 months

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

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