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510(k) K172078

Device
ImmuLisa Enhanced RNA POL III Antibody ELISA
Applicant
IMMCO Diagnostics, Inc.
510(k) number
K172078
Product code
NYO  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-30
Date received
2017-07-10
Regulation
866.5100
Classification name
Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kevin Lawson
Address
60 Pineview Dr. Buffalo NY US 14228 14228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202541EliA RNA Pol IIIPhadia AB2021-09-13
K070066QUANTA LITE RNA POL III ELISAInova Diagnostics, Inc.2007-04-11
K060431ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805Mbl International Corporation2006-06-19

Legacy Summary#

summary

FDA Review#

Decision Summary