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FDA 510(k) Application Details - K130524
Device Classification Name
Test, Urea (Breath Or Blood)
More FDA Info for this Device
510(K) Number
K130524
Device Name
Test, Urea (Breath Or Blood)
Applicant
EXALENZ BIOSCIENCE LTD.
11925 W I-70 FRONTAGE RD NORTH
SUITE 900
WHEAT RIDGE, CO 80033 US
Other 510(k) Applications for this Company
Contact
CLAY ANSELMO
Other 510(k) Applications for this Contact
Regulation Number
866.3110
More FDA Info for this Regulation Number
Classification Product Code
MSQ
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More FDA Info for this Product Code
Date Received
02/28/2013
Decision Date
05/22/2013
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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