Neuroganics L L C

FDA Filings

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

FDA Registration(s)

• Registration Number: 3016648714
• FEI Number: 3016648714
• Name: NEUROGANICS LLC
• Owner & Operator: Neuroganics LLC
• Contact Address: 10190 Bannock St #102 ; Northglenn CO 80260 US
• Official Correspondent:
  • Donald C Cooper
  • 1-720-4313495-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10190 Bannock St #102 ; Northglenn, CO 80260 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PQQ NEUROGANICS LLC	Mobile Assay mReader	2020-03-27
QKP NEUROGANICS LLC	COVID-19 Antigen Rapid Test (Emergency Use Authorization)	2020-03-26
QKP NEUROGANICS LLC	COVID-19 Antigen Rapid Test (EUA ALLOWED)	2020-03-26
QKO NEUROGANICS LLC	COVID-19 IgM/IgG Self-Test (Emergency Use Authorization)	2020-03-26
QKO NEUROGANICS LLC	COVID-19 IgM/IgG Rapid Test (Emergency Use Authorization)	2020-03-26
QKO NEUROGANICS LLC	COVID-19 IgM/IgG Rapid Test (EUA ALLOWED)	2020-03-26
QKO NEUROGANICS LLC	COVID-19 Antigen Rapid Test (Emergency Use Authorization)	2020-03-26
KFZ NEUROGANICS LLC	Therapeutic Respiratory Humidifier	2020-03-21
KFZ NEUROGANICS LLC	Home Sleep Therapeutic Respiratory Humidifier	2020-03-21
NNK NEUROGANICS LLC	SARS-COV-2 Swab and VTM Collection Kit	2020-03-20
NNK NEUROGANICS LLC	Coronavirus (Self-Swab) Collection for Rapid Diagnostic Kit	2020-03-20
NNK NEUROGANICS LLC	COVID-19 Serology Ag Test	2020-03-20
NNK NEUROGANICS LLC	COVID-19 Self-Swab Home Collection Kit	2020-03-20
NNK NEUROGANICS LLC	COVID-19 Self-Swab Collection Kit for Rapid Diagnostics	2020-03-20
NNK NEUROGANICS LLC	COVID-19 IgM/IgG Rapid Test (EUA ALLOWED)	2020-03-20