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FDA 510(k) Applications Submitted by RON DOMINGO
FDA 510(k) Number
Submission Date
Device Name
Applicant
K171963
06/30/2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
Hologic, Inc.
K162673
09/26/2016
Aptima Herpes Simplex Viruses 1 & 2 Assay
HOLOGIC, INC.
K153219
11/05/2015
ProFlu+ Assay
HOLOGIC, INC.
K153223
11/06/2015
ProParaFlu+ Assay
HOLOGIC, INC.
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