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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, uric, phosphotungstate reduction
510(k) Number K850933
Device Name URIC ACID
Applicant
DILAB, INC.
7003 N.W. 50TH ST.
MIAMI,  FL  33166
Applicant Contact RAFAEL A QUEVEDO
Correspondent
DILAB, INC.
7003 N.W. 50TH ST.
MIAMI,  FL  33166
Correspondent Contact RAFAEL A QUEVEDO
Regulation Number862.1775
Classification Product Code
CDH  
Date Received03/07/1985
Decision Date 06/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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