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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K850932
Device Name CREATININE
Applicant
Dilab, Inc.
7003 NW 50th St.
Miami,  FL  33166
Applicant Contact RAFAEL A QUEVEDO
Correspondent
Dilab, Inc.
7003 NW 50th St.
Miami,  FL  33166
Correspondent Contact RAFAEL A QUEVEDO
Regulation Number862.1225
Classification Product Code
CGX  
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
Predetermined Change
Control Plan Authorized		 No
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