ASTar BC G- Kit and ASTar Instrument— 510(k) K221688
Substantially EquivalentQ-Linea AB
FDA 510(k) clearance K221688 for ASTar BC G- Kit and ASTar Instrument, Substantially Equivalent on 2024-04-26. Applicant: Q-Linea AB. Device class: 2.
Clearance details
- Applicant
- Q-Linea AB
- 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
- Uppsala, SE
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.