ASTar BC G- Kit— 510(k) K253573
Substantially EquivalentQ-Linea AB
FDA 510(k) clearance K253573 for ASTar BC G- Kit, Substantially Equivalent on 2026-04-15. 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
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More clearances from Q-Linea AB
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