FDA 510(k) Application Details - K001943

Device Classification Name	Test,Carbohydrate Deficient Transferrin   More FDA Info for this Device
510(K) Number	K001943
Device Name	Test,Carbohydrate Deficient Transferrin
Applicant	SANGUI BIOTECH, INC. 1508 BROOKHOLLOW DR., #354 SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	JOHN J KIANG Other 510(k) Applications for this Contact
Regulation Number	862.1360   More FDA Info for this Regulation Number
Classification Product Code	NAO Other 510(k) Applications for this Device   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