R2 Diagnostics, Inc.
South Bend, IN, US
R2 DIAGNOSTICS, INC. appears in FDA device records in South Bend, IN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for R2 Diagnostics, Inc. between 2004 and 2011. The busiest year on record is 2004, with 3. The most recent is 2011, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 3 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102908 | NOFACT IX | GJT | Substantially Equivalent | |
| K102851 | NOFACT VIII | GJT | Substantially Equivalent | |
| K090105 | LUPOTEK KCT | GGW | Substantially Equivalent | |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | GIR | Substantially Equivalent | |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | GGP | Substantially Equivalent | |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | GGC | Substantially Equivalent | |
| K050817 | T-TEK | GJA | Substantially Equivalent | |
| K042919 | FIBROTEK FIB | GIS | Substantially Equivalent | |
| K040296 | PHOSPHOPLASTIN RL | GJS | Substantially Equivalent | |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | GGW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1835316 | 3000210416 | R2 DIAGNOSTICS, INC. | 1801 COMMERCE DR., SOUTH BEND, IN 46628 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GGCControl, Plasma, Abnormal
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- GIRReagent, Russel Viper Venom
- KQJSystem, Fibrinogen Determination
- GISTest, Fibrinogen
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain