Submission Details
| 510(k) Number | K210902 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 2021 |
| Decision Date | July 27, 2022 |
| Days to Decision | 488 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
EliA Ro52, EliA Ro60
Jul 2022
Decision
488d
Days
Class 2
Risk
About This 510(k) Submission
K210902 is an FDA 510(k) clearance for the EliA Ro52, EliA Ro60, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 27, 2022, 488 days after receiving the submission on March 26, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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