Anti RNA Polymerase III Elisa Kit, Model 7805

FDA 510(k) K060431 · Mbl International Corporation

Substantially Equivalent

510(k) numberK060431

Submission

Device name
Anti RNA Polymerase III Elisa Kit, Model 7805
Applicant
Mbl International Corporation
Deer Field, IL, US
Received
February 21, 2006
Decision date
June 19, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NYO – Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

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K202541EliA RNA Pol IIINYO · Traditional Phadia AB09/13/2021SE
K172078ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional Immco Diagnostics, Inc.03/30/2018SE
K070066Quanta Lite RNA Pol III ElisaNYO · Traditional Inova Diagnostics, Inc.04/11/2007SE

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Questions and answers

When was Anti RNA Polymerase III Elisa Kit, Model 7805 cleared by the FDA?

Anti RNA Polymerase III Elisa Kit, Model 7805 (K060431) received a 510(k) decision of Substantially Equivalent on June 19, 2006, 118 days after the submission was received.

What is the product code of K060431?

The FDA product code is NYO – Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody, a Class II (moderate risk) device regulated under 21 CFR 866.5100.