FDA 510(k) Applications Submitted by Biokit, S.A.

FDA 510(k) Number Submission Date Device Name Applicant
K152185 08/05/2015 ARCHITECT SHBG BIOKIT, S.A.
K213987 12/20/2021 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls Biokit, S.A.
K214068 12/27/2021 Quantia IgE Biokit, S.A.
K243575 11/19/2024 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls Biokit, S.A.
K181334 05/21/2018 ADVIA Centaur Herpes-2 IgG Biokit, S.A.
K181333 05/21/2018 ADVIA Centaur Herpes-1 IgG Biokit, S.A.


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