Panels › Microbiology › Product code QUT · Class 2
Deformability Cytometry For Sepsis Risk Assessment
Regulation 866.3215
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QUT
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytovale, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2025 | K250912 | IntelliSep Test Cytovale, Inc. | QUT |
| Mar 21, 2025 | K250513 | IntelliSep Test (CV-ICG-048) Cytovale, Inc. | QUT |
| Dec 20, 2022 | K220991 | IntelliSep test Cytovale, Inc. | QUT |
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