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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 K030754
Device Name A/C ENZYMATIC HOMOCYSTEINE ASSAY
Applicant
Anticancer, Inc.
7917 Ostrow St.
San Diego,  CA  92111
Applicant Contact YUYING TAN
Correspondent
Anticancer, Inc.
7917 Ostrow St.
San Diego,  CA  92111
Correspondent Contact YUYING TAN
Regulation Number862.1377
Classification Product Code
LPS  
Date Received03/10/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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