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FDA 510(k) Applications Submitted by DECLAN HYNES
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221197
04/25/2022
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho Clinical Diagnostics
K231525
05/26/2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho Clinical Diagnostics
K101921
07/09/2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
ORTHO-CLINICAL DIAGNOSTICS
K212648
08/23/2021
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho Clinical Diagnostics
K213626
11/17/2021
VITROS AFP
Ortho Clinical Diagnostics
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