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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
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