VITEK REVEAL GN AST Assay and VITEK REVEAL AST System— 510(k) K230675
Substantially EquivalentSpecific Diagnostics, LLC
FDA 510(k) clearance K230675 for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, Substantially Equivalent on 2024-06-20. Applicant: Specific Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Specific Diagnostics, LLC
- Product code
- Code SAN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code SAN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.