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FDA 510(k) Applications Submitted by Bin Sun
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220456
02/17/2022
Elecsys FT4 IV
Roche Diagnostics
K180684
03/15/2018
CoaguChek XS Plus System
Roche Diagnostics
K220911
03/29/2022
Elecsys CMV IgG
Roche Diagnostics
K211302
04/29/2021
Elecsys Syphilis
Roche Diagnostics
K221693
06/10/2022
Elecsys Anti-HCV II (08837031190)
Roche Diagnostics
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