R2 DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1835316	3000210416	R2 DIAGNOSTICS, INC.	1	N	2026-01-01	1801 COMMERCE DR. SOUTH BEND IN US 46628

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
52414	1083058313	K781880	ASSAY KIT, THROMBO-SCREEN	GIS	1978-12-04
52414	1870241072	K102908	NOFACT IX	GJT	2011-12-19
52414	1569811790	K102851	NOFACT VIII	GJT	2011-12-19
52414	1828472132	K090105	LUPOTEK KCT	GGW	2010-12-30
52414	1199482796	K083878	LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA	GIR	2010-06-25
52414	2037189415	K082631	THROMBO TEK PSE, MODEL 90-480	GGP	2008-12-17
52414	1661085670	K062306	PLASMACON N, PLASMACON L-1, PLASMACON L-2	GGC	2007-03-16
52414	1830393663	K050817	T-TEK	GJA	2005-12-12
52414	1363524415	K042919	FIBROTEK FIB	GIS	2004-11-29
52414	1581059005	K040296	PHOSPHOPLASTIN RL	GJS	2004-05-24
52414	1602895455	K033471	PHOSPHOLIN ES AND CALCIUM CHLORIDE	GGW	2004-02-04
52414	1345511611

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GJT	2	2011-12-19
GGW	2	2010-12-30
GIS	2	2004-11-29
GIR	1	2010-06-25
GGP	1	2008-12-17
GGC	1	2007-03-16
GJA	1	2005-12-12
GJS	1	2004-05-24

NOFACT IX
2011-12-19
R2 DIAGNOSTICS, INC.
NOFACT VIII
2011-12-19
R2 DIAGNOSTICS, INC.
LUPOTEK KCT
2010-12-30
R2 DIAGNOSTICS, INC.
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
2010-06-25
R2 DIAGNOSTICS, INC.
THROMBO TEK PSE, MODEL 90-480
2008-12-17
R2 DIAGNOSTICS, INC.
PLASMACON N, PLASMACON L-1, PLASMACON L-2
2007-03-16
R2 DIAGNOSTICS, INC.
T-TEK
2005-12-12
R2 DIAGNOSTICS, INC.
FIBROTEK FIB
2004-11-29
R2 DIAGNOSTICS, INC.
PHOSPHOPLASTIN RL
2004-05-24
R2 DIAGNOSTICS, INC.
PHOSPHOLIN ES AND CALCIUM CHLORIDE
2004-02-04
R2 DIAGNOSTICS, INC.