IntelliSep test
Cytovale, Inc.
CYTOVALE, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017448032 | 3017448032 | CYTOVALE, INC. | 1 | N | 2026-01-01 | 2 Tower Pl Fl 18 South San Francisco CA US 94080 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319810 | 1241778732 | K250912 | IntelliSep Test | QUT | 2025-11-19 |
| 319810 | 1430632494 | K250513 | IntelliSep Test (CV-ICG-048) | QUT | 2025-03-21 |
| 319810 | 1158956120 | K220991 | IntelliSep test | QUT | 2022-12-20 |
| 319810 | 1135574136 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QUT | 3 | 2025-11-19 |