510(k) K230675
- Device
- VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Applicant
- Specific Diagnostics, LLC
- 510(k) number
- K230675
- Product code
- SAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-20
- Date received
- 2023-03-10
- Regulation
- 866.1650
- Classification name
- Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jolyn Tenllado
- Address
- 130 Baytech Dr. San Jose CA US 95134 95134
FDA Registration Numbers#
- 3009171251
- 1950204
- 3027320620
- 3025772277
- 2022807
- 2919016
- 3023036790
Source Documents#
Other 510(k) Records For Product Code SAN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253573 | ASTar BC G- Kit | Q-Linea AB | 2026-04-15 |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2025-10-27 |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2024-10-23 |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-Linea AB | 2024-04-26 |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | 2024-04-02 |