510(k) K962888— AFFIRM ONE-STEP HOME PREGNANCY TEST
Substantially EquivalentAthena Medical Corp.
Clearance details
- Applicant
- Athena Medical Corp.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.