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FDA 510(k) Application Details - K001943
Device Classification Name
Test,Carbohydrate Deficient Transferrin
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510(K) Number
K001943
Device Name
Test,Carbohydrate Deficient Transferrin
Applicant
SANGUI BIOTECH, INC.
1508 BROOKHOLLOW DR., #354
SANTA ANA, CA 92705 US
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Contact
JOHN J KIANG
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Regulation Number
862.1360
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Classification Product Code
NAO
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More FDA Info for this Product Code
Date Received
06/26/2000
Decision Date
08/23/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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