R2 Diagnostics, Inc. - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - R2 Diagnostics, Inc. Hematology ✕
10 devices
Cleared
Dec 19, 2011
NOFACT VIII
Hematology
446d
Cleared
Dec 19, 2011
NOFACT IX
Hematology
444d
Cleared
Dec 30, 2010
LUPOTEK KCT
Hematology
714d
Cleared
Jun 25, 2010
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
Hematology
543d
Cleared
Dec 17, 2008
THROMBO TEK PSE, MODEL 90-480
Hematology
98d
Cleared
Mar 16, 2007
PLASMACON N, PLASMACON L-1, PLASMACON L-2
Hematology
220d
Cleared
Dec 12, 2005
T-TEK
Hematology
256d
Cleared
Nov 29, 2004
FIBROTEK FIB
Hematology
38d
Cleared
May 24, 2004
PHOSPHOPLASTIN RL
Hematology
105d
Cleared
Feb 04, 2004
PHOSPHOLIN ES AND CALCIUM CHLORIDE
Hematology
93d