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FDA 510(k) Applications for Medical Device Product Code "PGI"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN140004
DIAGNOSTIC HYBRIDS, INC.
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
05/13/2014
K173798
DiaSorin Molecular LLC
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
03/14/2018
K192376
DiaSorin Molecular LLC
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
11/26/2019
K180559
ELITechGroup
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
10/29/2018
K151906
LUMINEX CORPORATION
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
10/06/2015
K151046
MERIDIAN BIOSCIENCE, INC.
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
07/17/2015
K162451
QUIDEL CORPORATION
Solana HSV 1+2/VZV Assay
11/28/2016
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