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R2 Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K102851NOFACT VIIIDecember 19, 2011
K102908NOFACT IXDecember 19, 2011
K090105LUPOTEK KCTDecember 30, 2010
K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAJune 25, 2010
K082631THROMBO TEK PSE, MODEL 90-480December 17, 2008
K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2March 16, 2007
K050817T-TEKDecember 12, 2005
K042919FIBROTEK FIBNovember 29, 2004
K040296PHOSPHOPLASTIN RLMay 24, 2004
K033471PHOSPHOLIN ES AND CALCIUM CHLORIDEFebruary 4, 2004