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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Magnesium
510(k) Number K111915
Device Name MAGNESIUM ASSAY
Applicant
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown
Prince Edward Island,  CA C1E2B9
Applicant Contact PENNY J WHITE
Correspondent
Sekisui Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown
Prince Edward Island,  CA C1E2B9
Correspondent Contact PENNY J WHITE
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received07/06/2011
Decision Date 12/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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