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510(k) K832821

Device
FIAX IGG TEST
Applicant
INTL. DIAGNOSTIC TECHNOLOGY
510(k) number
K832821
Product code
DFI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-14
Date received
1983-08-19
Regulation
866.5860
Classification name
Total Spinal-fluid, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DFI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854190CANTROL SPINAL FLUID CONTROLCanyon Diagnostics, Inc.1985-11-25
K843122RESOLVE-CSFIsolab, Inc.1984-11-30
K840974SOMAS HUMAN SPINAL FLUID CONTROLSomas Medical Industries, Inc.1984-04-05

Legacy Summary#

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FDA Review#

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