EliA RNA Pol III
FDA 510(k) clearance K202541 · decided 2021-09-13
Clearance details
- K-number
- K202541
- Device name
- EliA RNA Pol III
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2020-09-02
- Decision date
- 2021-09-13
- Days to decision
- 376 days
- Clearance type
- Traditional
- Product code
- NYO
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) | Immco Diagnostics, Inc. | 2018-03-30 |
| QUANTA LITE RNA POL III ELISA (K070066) | Inova Diagnostics, Inc. | 2007-04-11 |
| ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (K060431) | Mbl International Corporation | 2006-06-19 |
Recalls involving this device
No recalls on record reference this clearance.