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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease, Photometric, Urea Nitrogen
510(k) Number K123322
Device Name ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Applicant Contact HYMAN KATZ PH.D.
Correspondent
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Correspondent Contact HYMAN KATZ PH.D.
Regulation Number862.1770
Classification Product Code
CDN  
Subsequent Product Codes
CGS   CGX   KNK  
Date Received10/26/2012
Decision Date 05/21/2013
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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