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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K974306
Device Name SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
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 Number862.1545
Classification Product Code
CEW  
Date Received11/17/1997
Decision Date 12/23/1997
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
Recalls CDRH Recalls
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