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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Carbohydrate Deficient Transferrin
510(k) Number K992502
Device Name AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
Applicant
Axis
P.O. Box 262069
San Diego,  CA  92196
Applicant Contact RONALD G LEONARDI
Correspondent
Axis
P.O. Box 262069
San Diego,  CA  92196
Correspondent Contact RONALD G LEONARDI
Regulation Number862.1360
Classification Product Code
NAO  
Date Received07/26/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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