EliA RNA Pol III
FDA 510(k) K202541 · Phadia AB
510(k) numberK202541
Submission
- Device name
- EliA RNA Pol III
- Applicant
- Phadia AB
Uppsala, SE - Received
- September 2, 2020
- Decision date
- September 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | Immco Diagnostics, Inc. | 03/30/2018SE |
| 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 EliA RNA Pol III cleared by the FDA?
EliA RNA Pol III (K202541) received a 510(k) decision of Substantially Equivalent on September 13, 2021, 376 days after the submission was received.
What is the product code of K202541?
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.