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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K864456
Device Name CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
Applicant
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Applicant Contact JAMES F GODFREY
Correspondent
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Correspondent Contact JAMES F GODFREY
Regulation Number862.3280
Classification Product Code
LAS  
Date Received11/13/1986
Decision Date 05/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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