R2 Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for R2 Diagnostics 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: 1835316
• FEI Number: 3000210416
• Name: R2 DIAGNOSTICS, INC.
• Owner & Operator: R2 DIAGNOSTICS, INC.
• Contact Address: 1801 COMMERCE DR. --; SOUTH BEND IN 46628 US
• Official Correspondent:
  • MICHAEL J MORRIS
  • x-574-2884377-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1801 COMMERCE DR. ; SOUTH BEND, IN 46628 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GGN R2 DIAGNOSTICS, INC.	Plasmaref ARN	2016-05-05
GGN R2 DIAGNOSTICS, INC.	Plasmaref ARL-2	2016-05-05
PMN K090105 | GGW R2 DIAGNOSTICS, INC.	Lupotek KCT	2015-10-21
PMN K102908 | GJT R2 DIAGNOSTICS, INC.	NOFACT IX	2013-01-07
PMN K102851 | GJT R2 DIAGNOSTICS, INC.	NOFACT VIII	2013-01-07
PMN K102908 R2 DIAGNOSTICS, INC.	NOFACT IX	2011-12-19
PMN K102851 R2 DIAGNOSTICS, INC.	NOFACT VIII	2011-12-19
PMN K090105 R2 DIAGNOSTICS, INC.	LUPOTEK KCT	2010-12-30
PMN K083878 | GIR R2 DIAGNOSTICS, INC.	LupoTek CorrecTin VL, DetecTin VL, PlasmaConLA	2010-12-22
PMN K083878 | GGC R2 DIAGNOSTICS, INC.	LupoTek CorrecTin VL, DetecTin VL, PlasmaConLA	2010-12-22
PMN K083878 R2 DIAGNOSTICS, INC.	LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA	2010-06-25
PMN K781880 | GIS R2 DIAGNOSTICS, INC.	FIB Calibrator	2009-03-20
PMN K082631 | GGP R2 DIAGNOSTICS, INC.	ThromboTek PSe	2009-03-19
PMN K082631 R2 DIAGNOSTICS, INC.	THROMBO TEK PSE, MODEL 90-480	2008-12-17
PMN K062306 | GIZ R2 DIAGNOSTICS, INC.	PLASMACON	2007-12-18
PMN K062306 | GGC R2 DIAGNOSTICS, INC.	PLASMACON	2007-12-18
PMN K062306 R2 DIAGNOSTICS, INC.	PLASMACON N, PLASMACON L-1, PLASMACON L-2	2007-03-16
PMN K042919 | KQJ R2 DIAGNOSTICS, INC.	FIBRO TEK FIB	2006-09-25
PMN K042919 | GIS R2 DIAGNOSTICS, INC.	FIBRO TEK FIB	2006-09-25
PMN K050817 R2 DIAGNOSTICS, INC.	T-TEK	2005-12-12
PMN K042919 R2 DIAGNOSTICS, INC.	FIBROTEK FIB	2004-11-29
PMN K040296 R2 DIAGNOSTICS, INC.	PHOSPHOPLASTIN RL	2004-05-24
PMN K033471 R2 DIAGNOSTICS, INC.	PHOSPHOLIN ES AND CALCIUM CHLORIDE	2004-02-04
PMN K040296 | GJS R2 DIAGNOSTICS, INC.	PHOSPHOPLASTIN-RL	2003-11-12
PMN K033471 | GGW R2 DIAGNOSTICS, INC.	PHOSPHOLLIN-ES AND CALCIUM CHLORIDE	2003-11-12
PMN K050817 | GJA R2 DIAGNOSTICS, INC.	T-TEK	1996-06-12