510(k) K202541
- Device
- EliA RNA Pol III
- Applicant
- Phadia AB
- 510(k) number
- K202541
- Product code
- NYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-13
- Date received
- 2020-09-02
- 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
- Sheryl Skinner
- Address
- Rapsgatan 7p P.O. Box 6460 Uppsala SE 751 37 751 37
FDA Registration Numbers#
- 8043792
- 9680745
- 2026994
- 3039353646
- 3004973408
- 9610566
Source Documents#
Other 510(k) Records For Product Code NYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Immco Diagnostics, Inc. | 2018-03-30 |
| K070066 | QUANTA LITE RNA POL III ELISA | Inova Diagnostics, Inc. | 2007-04-11 |
| K060431 | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 | Mbl International Corporation | 2006-06-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary