FDA Product Code
FDA Product Code QUT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3215
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250912 | IntelliSep Test | Cytovale, Inc. | 2025-11-19 | Traditional | PDF ↗ |
| K250513 | IntelliSep Test (CV-ICG-048) | Cytovale, Inc. | 2025-03-21 | Special | PDF ↗ |
| K220991 | IntelliSep test | Cytovale, Inc. | 2022-12-20 | Traditional | PDF ↗ |
Product code QUT · Class II · Microbiology. Data: openFDA.