DC-UIBC-CAL— 510(k) K163078
Substantially EquivalentSekisui Diagnostics P.E.I., Inc.
FDA 510(k) clearance K163078 for DC-UIBC-CAL, Substantially Equivalent on 2016-12-08. Applicant: Sekisui Diagnostics P.E.I., Inc..
Clearance details
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Product code
- 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.