MAGNESIUM ASSAY— 510(k) K111915

Substantially Equivalent

Sekisui 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..

Clearance details

Applicant: Sekisui Diagnostics P.E.I., Inc.
Product code: Code JGJ
Advisory panel: Clinical Chemistry
Date received: 2011-07-06
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prince Edward Island, CA

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.