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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 K103615
Device Name ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1770
Classification Product Code
CDN  
Subsequent Product Codes
CEO   CGX   CJY   JIX  
Date Received12/09/2010
Decision Date 09/08/2011
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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