510(k) K960117— PLATFORM ONESTEP PREGNANCY HOME TEST
Substantially EquivalentSyntron Bioresearch, Inc.
Clearance details
- Applicant
- Syntron Bioresearch, Inc.
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.