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FDA 510(k) Application Details - K092817
Device Classification Name
Test, Urea (Breath Or Blood)
More FDA Info for this Device
510(K) Number
K092817
Device Name
Test, Urea (Breath Or Blood)
Applicant
OTSUKA PHARMACEUTICAL CO., LTD.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
CYNTHIA A SINCLAIR
Other 510(k) Applications for this Contact
Regulation Number
866.3110
More FDA Info for this Regulation Number
Classification Product Code
MSQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2009
Decision Date
03/09/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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