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510(k) K070066

Device
QUANTA LITE RNA POL III ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K070066
Product code
NYO  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-11
Date received
2007-01-08
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRYS C MYERS
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202541EliA RNA Pol IIIPhadia AB2021-09-13
K172078ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc.2018-03-30
K060431ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805Mbl International Corporation2006-06-19

Legacy Summary#

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FDA Review#

Decision Summary