FDA 510(k) Application Details - K132167

Device Classification Name	Automated Occult Blood Analyzer   More FDA Info for this Device
510(K) Number	K132167
Device Name	Automated Occult Blood Analyzer
Applicant	Boditech Med Inc. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON CHUNCHEON-SI, GANG-WON-DO 200-883 KR Other 510(k) Applications for this Company
Contact	SANG YEOL PARK Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	OOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2013
Decision Date	05/02/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review