510(k) K181551— DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
Substantially EquivalentRunbio Biotech Co.,Ltd
Clearance details
- Applicant
- Runbio Biotech Co.,Ltd
- Product code
- Code LCX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.