ANTIMICROBIAL REMOVAL DEVICE (ARD)

Device, Antimicrobial Drug Removal

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Antimicrobial Removal Device (ard).

Pre-market Notification Details

Device IDK822344
510k NumberK822344
Device Name:ANTIMICROBIAL REMOVAL DEVICE (ARD)
ClassificationDevice, Antimicrobial Drug Removal
Applicant MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLJF  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-05
Decision Date1982-08-25

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