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510(k) K822344

Device
ANTIMICROBIAL REMOVAL DEVICE (ARD)
Applicant
MARION LABORATORIES, INC.
510(k) number
K822344
Product code
LJF  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-25
Date received
1982-08-05
Regulation
866.2560
Classification name
Device, Antimicrobial Drug Removal
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003104BACT/ALERT CSROrganon Teknika Corp.2000-10-20
K830372ARTIMICROBIAL REMOVAL DEVICEMarion Laboratories, Inc.1983-04-08
K830363BACTEC 170 TRYPTIC SOY BROTH W/RESINSBd Becton Dickinson Vacutainer Systems Preanalytic1983-03-24

Legacy Summary#

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FDA Review#

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