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FDA 510(k) Applications Submitted by Nikita Malladi
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200033
01/07/2020
HemosIL von Willebrand Factor Antigen
Instrumentation Laboratory Co.
K170314
02/01/2017
ACL AcuStar
INSTRUMENTATION LABORATORY CO.
K160276
02/02/2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
INSTRUMENTATION LABORATORY CO.
K221359
05/11/2022
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM
Instrumentation Laboratory Co.
K151534
06/08/2015
HemosIL D-Dimer HS
INSTRUMENTATION LABORATORY CO.
K161818
07/01/2016
GEM Premier 3000
Instrumentation Laboratory Co.
K223402
11/09/2022
HemosIL von Willebrand Factor Antigen
Instrumentation Laboratory Co.
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