VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Specific Diagnostics, LLC
Specific Diagnostics
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023036790 | 3023036790 | Specific Diagnostics | 1 | N | 2026-01-01 | 130 Baytech Dr San Jose CA US 95134 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 309859 | 1047179699 | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | 2024-06-20 |
| 309859 | 1026215709 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SAN | 1 | 2024-06-20 |