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510(k) K830372

Device
ARTIMICROBIAL REMOVAL DEVICE
Applicant
MARION LABORATORIES, INC.
510(k) number
K830372
Product code
LJF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-08
Date received
1983-02-04
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K830363BACTEC 170 TRYPTIC SOY BROTH W/RESINSBd Becton Dickinson Vacutainer Systems Preanalytic1983-03-24
K822344ANTIMICROBIAL REMOVAL DEVICE (ARD)Marion Laboratories, Inc.1982-08-25

Legacy Summary#

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FDA Review#

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