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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 K122302
Device Name ACE MAGNESIUM REGENT
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1495
Classification Product Code
JGJ  
Date Received08/01/2012
Decision Date 08/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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