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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K992846
Device Name HICHEM TOTAL PROTEIN REAGENT
Applicant
ELAN HOLDINGS, INC.
231 NORTH PUENTE ST.
BREA,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
ELAN HOLDINGS, INC.
231 NORTH PUENTE ST.
BREA,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/24/1999
Decision Date 10/18/1999
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
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