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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K980907
Device Name AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
Applicant
Axis Biochemicals, Asa
P.O. Box 262069
San Diego,  CA  92196
Applicant Contact RONALD G LEONARDI
Correspondent
Axis Biochemicals, Asa
P.O. Box 262069
San Diego,  CA  92196
Correspondent Contact RONALD G LEONARDI
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
DFC   JJX  
Date Received03/10/1998
Decision Date 10/16/1998
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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