DxNow Inc.

FDA Device Registration & Listing · Gaithersburg, MD, US · Registration 3014527900

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014527900
FEI Number
3014527900
Entity Name
DxNow Inc.
City/State/Country
Gaithersburg, MD, US
Establishment Address
401 Professional Drive, Suite 130, Gaithersburg, MD 20879, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
DxNow, Inc. (Owner Number: 10057557)
Owner / Operator Contact Address
401 Professional Drive, Suite 130, Gaithersburg, MD 20879, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K173075
PMA Number
N/A

All Registered Proprietary Names

ZyMot Multi Sperm Separation Device ZyMot ICSI Sperm Separation Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2018-04-24

Official Correspondent

Brian Szeremeta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DxNow, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014527900. Last updated year: 2026. Please use registration number 3014527900 when referencing this establishment in official correspondence.
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