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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythropoietin
510(k) Number K992799
Device Name SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
Applicant
Sangui Biotech, Inc.
1508 Brookhollow Dr., #354
Santa Ana,  CA  92705
Applicant Contact JOHN J KIANG
Correspondent
Sangui Biotech, Inc.
1508 Brookhollow Dr., #354
Santa Ana,  CA  92705
Correspondent Contact JOHN J KIANG
Regulation Number864.7250
Classification Product Code
GGT  
Date Received08/19/1999
Decision Date 06/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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