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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 K991387
Device Name ELAN ALKALINE PHOSPHATE REAGENT KIT
Applicant
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Applicant Contact RALPH BOLSTAD
Correspondent
Elan Holdings, Inc.
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact RALPH BOLSTAD
Regulation Number862.1050
Classification Product Code
CJE  
Date Received04/21/1999
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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