Panels › Microbiology › Product code QPS · Class 2
Immunoassay For Host Biomarkers Of Infection
Regulation 866.3215
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QPS
| Company | 510(k)s | Recalls |
|---|---|---|
| MeMed Diagnostics, Ltd. | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 0 |
| DiaSorin, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2026 | K261109 | Access MeMed BV Beckman Coulter, Inc. | QPS |
| Jun 30, 2023 | K230944 | MeMed BV MeMed Diagnostics, Ltd., IL | QPS |
| Mar 23, 2023 | K222332 | MeMed BV MeMed Diagnostics, Ltd., IL | QPS |
| Jul 14, 2022 | K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set DiaSorin, Inc. | QPS |
| Sep 1, 2021 | K210254 | MeMed BV MeMed Diagnostics, Ltd., IL | QPS |
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