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FDA 510(k) Applications Submitted by Andre Hsiung
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160512
02/24/2016
HardyCHROM ESBL
HARDY DIAGNOSTICS
K062245
08/02/2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
HARDY DIAGNOSTICS
K172621
08/31/2017
HardyDisk Meropenem/Vaborbactam 20/10╡g (MEV30)
Hardy Diagnostics
K072827
10/03/2007
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
REMEL, INC.
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