LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System— 510(k) K211815
Substantially EquivalentAffinity Biosensors
FDA 510(k) clearance K211815 for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System, Substantially Equivalent on 2024-04-02. Applicant: Affinity Biosensors. Device class: 2.
Clearance details
- Applicant
- Affinity Biosensors
- 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
- Santa Barbara, CA, US
Recent devices under product code SAN
view all- K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel
- K253573 — ASTar BC G- Kit
- K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Data sourced from openFDA. This site is unofficial and independent of the FDA.