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510(k) K842969

Device
ALLERGENETICS ALLER-SPECIFIC IGE SERUM
Applicant
ALLERGENETICS
510(k) number
K842969
Product code
DGP  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-28
Date received
1984-07-30
Regulation
866.5510
Classification name
Ige, Fitc, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Clinical Chemistry
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 DGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931224VIDAS TOTAL IGE (IGE) ASSAYBiomerieux Vitek, Inc.1993-05-20
K863327IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.1986-12-03
K842749FIAX TOTAL IGE TEST KITIntl. Diagnostic Technology1984-08-28

Legacy Summary#

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FDA Review#

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