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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 K912825
Device Name MAGNESIUM ASSAY KIT, CAT.# 100-12
Applicant
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact KAREN CALLBECK
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received06/26/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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