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510(k) K931224

Device
VIDAS TOTAL IGE (IGE) ASSAY
Applicant
BIOMERIEUX VITEK, INC.
510(k) number
K931224
Product code
DGP  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-20
Date received
1993-03-10
Regulation
866.5510
Classification name
Ige, Fitc, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VICKI ANASTASI
Address
1022 Hingham St. Rockland MA US 02370 02370

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863327IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.1986-12-03
K842749FIAX TOTAL IGE TEST KITIntl. Diagnostic Technology1984-08-28
K842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMAllergenetics1984-08-28

Legacy Summary#

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FDA Review#

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