K163078
Substantially EquivalentDC-UIBC-CAL
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Product code
- JIT
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Charlottetown,, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.