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510(k) K831609

Device
FIAX IGG TEST KIT
Applicant
INTL. DIAGNOSTIC TECHNOLOGY
510(k) number
K831609
Product code
DGK  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-17
Date received
1983-05-18
Regulation
866.5510
Classification name
Igg, Fitc, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
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 DGK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831908RABBIT ANTISERUM TO HUMAN IGGDako Corp.1983-07-18

Legacy Summary#

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FDA Review#

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