One Step Pregnancy Test— 510(k) K210341
Substantially EquivalentSpd Swiss Precision Diagnostics GmbH
FDA 510(k) clearance K210341 for One Step Pregnancy Test, Substantially Equivalent on 2022-03-10. Applicant: Spd Swiss Precision Diagnostics GmbH.
Clearance details
- Applicant
- Spd Swiss Precision Diagnostics GmbH
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, CH
Data sourced from openFDA. This site is unofficial and independent of the FDA.