MAGNESIUM ASSAY— 510(k) K111915
Substantially EquivalentSekisui Diagnostics P.E.I., Inc.
FDA 510(k) clearance K111915 for MAGNESIUM ASSAY, Substantially Equivalent on 2011-12-02. Applicant: Sekisui Diagnostics P.E.I., Inc.. Device class: 1.
Clearance details
- Applicant
- Sekisui Diagnostics P.E.I., Inc.
- Product code
- Code JGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1495
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prince Edward Island, CA
Recent devices under product code JGJ
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