SEKURE HbA1c Assay— 510(k) K173206
Substantially EquivalentSekisui Diagnostics P.E.I., Inc.
FDA 510(k) clearance K173206 for SEKURE HbA1c Assay, Substantially Equivalent on 2018-07-12. Applicant: Sekisui Diagnostics P.E.I., Inc.. Device class: 2.
Clearance details
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Product code
- Code PDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1373
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottetown,, CA
Recent devices under product code PDJ
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