Arj Medical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004577174
• FEI Number: 3004577174
• Name: ARJ MEDICAL, INC.
• Owner & Operator: ARJ MEDICAL, INC.
• Contact Address: 209 STATE STREET EAST --; Oldsmar FL 34677 US
• Official Correspondent:
  • PHILIP - ROSS
  • x-813-8551557-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 209 STATE STREET EAST ; OLDSMAR, FL 34677 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00860001810387 Arj Medical, Inc.	PyloPlus+ Urea Breath Test Lab Analyzer	2025-01-28
GUDID 00860001810370 Arj Medical, Inc.	PyloPlus+ Urea Breath Test Pro Analyzer	2025-01-28
GUDID 00860001810363 Arj Medical, Inc.	PyloPlus+ Urea Breath Test Analyzer	2025-01-28
GUDID 00860001810325 Arj Medical, Inc.	PyloPlus+ Urea Breath Test Kit	2025-01-28
PMN P170022 | OZA ARJ MEDICAL, INC.	PyloPlus Urea Breath Test	2020-03-03
PMN P170022 | OZA ARJ MEDICAL, INC.	PyloPlus UBT System	2020-03-03
PMN P170022 | OZA ARJ MEDICAL, INC.	PyloPlus 13C Urea Breath Test	2020-03-03
PMA P170022 ARJ Medical Inc.	PyloPlus UBT System	2020-02-18
PMN K091472 ARJ MEDICAL, INC.	URITEST 50 AND URITEST 500 URINE ANALYZER	2010-04-27
PMN K052719 | LJX ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JRE ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JMT ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JJB ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JIR ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JIO ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JIN ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | JIL ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | CEN ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052719 | CDM ARJ MEDICAL, INC.	Uritest 10	2007-02-06
PMN K052708 | LYR ARJ MEDICAL, INC.	PYLO PLUS	2007-02-06
PMN K052719 ARJ MEDICAL, INC.	URITEST 10 URINALYSIS REAGENT STRIPS	2006-12-05
PMN K052708 ARJ MEDICAL, INC.	PYLO-PLUS	2006-05-01

Similar & Related FDA Registered Companies

• ARJO WIGGINS MEDICAL, INC.
• ARJ Medical Inc.209 State Street Eoldsmar, FL 34677 PMA NumberP170022 Supplement NumberS001 Date Received05/04/2022 Decision Date11/30/2022 Product Code OZA  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No