SEKURE Creatine Kinase Assay— 510(k) K182702
Substantially EquivalentSekisui Diagnostics P.E.I., Inc.
FDA 510(k) clearance K182702 for SEKURE Creatine Kinase Assay, Substantially Equivalent on 2019-04-17. Applicant: Sekisui Diagnostics P.E.I., Inc.. Device class: 2.
Clearance details
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown,, CA
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More clearances from Sekisui Diagnostics P.E.I., Inc.
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