Cleared Traditional

ANTIMICROBIAL REMOVAL DEVICE (ARD)

K822344 · Marion Laboratories, Inc. · Microbiology

Aug 1982

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K822344 is an FDA 510(k) clearance for the ANTIMICROBIAL REMOVAL DEVICE (ARD), a Device, Antimicrobial Drug Removal (Class I — General Controls, product code LJF), submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1982, 20 days after receiving the submission on August 5, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K822344 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1982
Decision Date	August 25, 1982
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—