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510(k) K171731

Device
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Applicant
Kronus, Inc.
510(k) number
K171731
Product code
OIF  
Decision
Substantially Equivalent (SESE)
Decision date
2018-01-19
Date received
2017-06-12
Regulation
866.5660
Classification name
Tyrosine Phosphatase (ia-2) Autoantibody Assay
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Brian Deis
Address
170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OIF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, Inc.2023-08-24
K073590KRONUS IA-2 AUTOANTIBODY RIA ASSAY KITKronus Market Development Associates, Inc.2008-04-10

Legacy Summary#

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FDA Review#

Decision Summary