FDA 510(k) Application Details - K040703

Device Classification Name	Blood, Occult, Colorimetric, In Urine   More FDA Info for this Device
510(K) Number	K040703
Device Name	Blood, Occult, Colorimetric, In Urine
Applicant	DIRUI INDUSTRIAL CO., LTD. 7560 LINDBERGH DRIVE GAITHERSBURG, MD 20879 US Other 510(k) Applications for this Company
Contact	JOSEPH F LUDFORD Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	JIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2004
Decision Date	08/26/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review