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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K915503
Device Name FIBRINOGEN FDP CONTROL
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 Number864.7320
Classification Product Code
DAP  
Date Received12/09/1991
Decision Date 01/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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