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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K111260
Device Name A/C ENZYMATIC VITAMIN B6 ASSAY
Applicant
Anticancer, Inc.
7917 Ostrow St.
San Diego,  CA  92111
Applicant Contact QINGHONG HAN
Correspondent
Anticancer, Inc.
7917 Ostrow St.
San Diego,  CA  92111
Correspondent Contact QINGHONG HAN
Regulation Number862.1810
Classification Product Code
CDD  
Date Received05/05/2011
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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