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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K853203
Device Name ULTRACLONE ECL-01-2200 CELL LINE
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 Number864.2280
Classification Product Code
KIR  
Date Received07/30/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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