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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K850907
Device Name CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
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 Number862.1660
Classification Product Code
JJT  
Date Received03/05/1985
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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