Dxnow Inc

FDA Filings

This page includes the latest FDA filings for Dxnow Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Dxnow Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3014527900
FEI Number3014527900
NameDxNow Inc.
Owner & OperatorDxNow, Inc.
Contact Address401 Professional Drive Suite 130
Gaithersburg MD 20879 US
Official Correspondent
  • William T Sharp
  • 001-240-4549893-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address401 Professional Drive Suite 130
Gaithersburg, MD 20879 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
DXNOW, INC.
ZyMot ZPH13002021-08-24
DXNOW, INC.
ZyMot ZMH30002021-08-24
DXNOW, INC.
ZyMot ZPH13002021-03-05
DXNOW, INC.
ZyMot ZPH18502021-03-05
DXNOW, INC.
ZyMot ZPH10022021-03-05
DXNOW, INC.
ZyMot ZPH18502021-03-05
DxNow Inc. [DxNow, Inc.]
ZyMot Multi Sperm Separation Device2018-04-24
DxNow Inc. [DxNow, Inc.]
ZyMot ICSI Sperm Separation Device2018-04-24
DxNow, Inc.
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)2018-03-08

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