510(k) K970008— ADVANCED QUALITY PREGNANCY TEST
Substantially EquivalentBionike, Inc.
Clearance details
- Applicant
- Bionike, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.