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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K963383
Device Name HICHEM ALP/AMP REAGENT KIT
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1050
Classification Product Code
CKF  
Date Received08/27/1996
Decision Date 09/23/1996
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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