Prismira— 510(k) K243729
Substantially EquivalentLumos Labs, Inc.
FDA 510(k) clearance K243729 for Prismira, Substantially Equivalent on 2025-06-13. Applicant: Lumos Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Lumos Labs, Inc.
- Product code
- Code QFT
- Device class
- Class 2
- Regulation
- 21 CFR 882.5803
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code QFT
view allData sourced from openFDA. This site is unofficial and independent of the FDA.