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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nitrophenylphosphate, alkaline phosphatase or isoenzymes
510(k) Number K131351
Device Name ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
4 HENDERSON DR.
WEST CALDWELL,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
4 HENDERSON DR.
WEST CALDWELL,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1050
Classification Product Code
CJE  
Subsequent Product Codes
CIJ   CIT   CKA  
Date Received05/10/2013
Decision Date 08/15/2013
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
Recalls CDRH Recalls
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