ImmuLisa Enhanced RNA POL III Antibody ELISA

Q: What is the product code of K172078?

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.

FDA 510(k) K172078 · Immco Diagnostics, Inc.

Substantially Equivalent

510(k) numberK172078

Submission

Device name: ImmuLisa Enhanced RNA POL III Antibody ELISA
Applicant: Immco Diagnostics, Inc.
Buffalo, NY, US
Received: July 10, 2017
Decision date: March 30, 2018
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.

Other 510(k)s with product code NYO

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K202541	EliA RNA Pol IIINYO · Traditional	Phadia AB	09/13/2021SE
K070066	Quanta Lite RNA Pol III ElisaNYO · Traditional	Inova Diagnostics, Inc.	04/11/2007SE
K060431	Anti RNA Polymerase III Elisa Kit, Model 7805NYO · Traditional	Mbl International Corporation	06/19/2006SE

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Questions and answers

When was ImmuLisa Enhanced RNA POL III Antibody ELISA cleared by the FDA?

ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) received a 510(k) decision of Substantially Equivalent on March 30, 2018, 263 days after the submission was received.

What is the product code of K172078?

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.