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Company · US

R2 Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2011. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GGW	Test, Time, Partial Thromboplastin	2
GJT	Plasma, Coagulation Factor Deficient	2
GGC	Control, Plasma, Abnormal	1
GGP	Test, Qualitative And Quantitative Factor Deficiency	1
GIR	Reagent, Russel Viper Venom	1
GIS	Test, Fibrinogen	1
GJA	Test, Thrombin Time	1
GJS	Test, Time, Prothrombin	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Dec 19, 2011	K102908	NOFACT IX R2 Diagnostics, Inc.	GJT
Dec 19, 2011	K102851	NOFACT VIII R2 Diagnostics, Inc.	GJT
Dec 30, 2010	K090105	LUPOTEK KCT R2 Diagnostics, Inc.	GGW
Jun 25, 2010	K083878	LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA R2 Diagnostics, Inc.	GIR
Dec 17, 2008	K082631	THROMBO TEK PSE, MODEL 90-480 R2 Diagnostics, Inc.	GGP
Mar 16, 2007	K062306	PLASMACON N, PLASMACON L-1, PLASMACON L-2 R2 Diagnostics, Inc.	GGC
Dec 12, 2005	K050817	T-TEK R2 Diagnostics, Inc.	GJA
Nov 29, 2004	K042919	FIBROTEK FIB R2 Diagnostics, Inc.	GIS
May 24, 2004	K040296	PHOSPHOPLASTIN RL R2 Diagnostics, Inc.	GJS
Feb 4, 2004	K033471	PHOSPHOLIN ES AND CALCIUM CHLORIDE R2 Diagnostics, Inc.	GGW

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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