Cleared Traditional

ARTIMICROBIAL REMOVAL DEVICE

K830372 · Marion Laboratories, Inc. · Microbiology

Apr 1983

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K830372 is an FDA 510(k) clearance for the ARTIMICROBIAL REMOVAL DEVICE, a Device, Antimicrobial Drug Removal (Class I — General Controls, product code LJF), submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 8, 1983, 63 days after receiving the submission on February 4, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K830372 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1983
Decision Date	April 08, 1983
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—