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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact