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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nadh oxidation/nad reduction, alt/sgpt
510(k) Number K113382
Device Name ACE ALT REAGENT
Applicant
ALFA WASSERMANN
4 Henderson Drive
Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
ALFA WASSERMANN
4 Henderson Drive
Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1030
Classification Product Code
CKA  
Subsequent Product Codes
CIT   JPZ  
Date Received11/16/2011
Decision Date 07/19/2012
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
Recalls CDRH Recalls
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