FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream— 510(k) K243573
Substantially EquivalentAssure Tech., LLC
FDA 510(k) clearance K243573 for FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream, Substantially Equivalent on 2025-01-15. Applicant: Assure Tech., LLC.
Clearance details
- Applicant
- Assure Tech., LLC
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.