Data / Medical devices / United States / R2 Diagnostics, Inc.
R2 Diagnostics, Inc.: FDA-registered device maker in South Bend, IN, United States, 10 510(k) clearances
R2 Diagnostics, Inc. is registered with the FDA (registration 1835316) in South Bend, IN, United States. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 19, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1835316
- FEI number
- 3000210416
- Address
- 1801 Commerce DR., South Bend, IN, United States, 46628
- Owner or operator
- R2 DIAGNOSTICS, INC. (9026432)
- Roles
- Manufacturer
- First device listed
- June 12, 1996
- Registered through
- 2027
- Brand names listed
- FIBRO TEK FIB, LupoTek CorrecTin VL, DetecTin VL, PlasmaConLA, Lupotek KCT, NOFACT IX, NOFACT VIII, PHOSPHOLLIN-ES AND CALCIUM CHLORIDE, PHOSPHOPLASTIN-RL, PLASMACON and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Factor Deficient | GJT | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Control, Normal | GIZ | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Russel Viper Venom | GIR | 1 | Manufacturer | accessdata.fda.gov |
| System, Fibrinogen Determination | KQJ | 2 | Manufacturer | accessdata.fda.gov |
| Test, Fibrinogen | GIS | 2 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Thrombin Time | GJA | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Prothrombin | GJS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2011 | K102908 | NOFACT IX | GJT | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| December 19, 2011 | K102851 | NOFACT VIII | GJT | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| December 30, 2010 | K090105 | LUPOTEK KCT | GGW | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| June 25, 2010 | K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | GIR | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| December 17, 2008 | K082631 | THROMBO TEK PSE, MODEL 90-480 | GGP | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| March 16, 2007 | K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | GGC | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| December 12, 2005 | K050817 | T-TEK | GJA | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| November 29, 2004 | K042919 | FIBROTEK FIB | GIS | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| May 24, 2004 | K040296 | PHOSPHOPLASTIN RL | GJS | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| February 4, 2004 | K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | GGW | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plasma, Coagulation Factor Deficient
- All makers of Test, Fibrinogen
- All makers of System, Fibrinogen Determination
- All makers of Test, Qualitative And Quantitative Factor Deficiency
- All makers of Test, Thrombin Time
- All makers of Test, Time, Prothrombin
Updated December 19, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.