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510(k) K843570

Device
FIAX HAPTOGLOBIN TEST KIT
Applicant
INTL. DIAGNOSTIC TECHNOLOGY
510(k) number
K843570
Product code
DAB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-05
Date received
1984-09-11
Regulation
866.5460
Classification name
Haptoglobin, 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 DAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913670HAPTOGLOBIN IMMUNOLOGICAL TEST KITThe Binding Site, Ltd.1991-12-09
K772078RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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