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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K131515
Device Name ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
Applicant
Alfa Wassermann
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ, PH.D.
Correspondent
Alfa Wassermann
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ, PH.D.
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Codes
CHI   JPZ  
Date Received05/28/2013
Decision Date 08/14/2013
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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