510(k) K981892— QUICK & SURE ONESTEP HOME PREGNANCY TEST
Substantially EquivalentAbacus Diagnostics
Clearance details
- Applicant
- Abacus Diagnostics
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Hills, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.