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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K854206
Device Name ULTRACLONE 05-100 GUINEA PIG RBC
Applicant
Earl-Clay Laboratories, Inc.
890 Lamont Ave.
Novato,  CA  94947
Applicant Contact ROBERT E LOVINS
Correspondent
Earl-Clay Laboratories, Inc.
890 Lamont Ave.
Novato,  CA  94947
Correspondent Contact ROBERT E LOVINS
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/16/1985
Decision Date 10/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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