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FDA 510(k) Applications Submitted by Angels Roma
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.
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