R2 Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “R2 Diagnostics, Inc.” (first 2004, latest 2011), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 238 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | 2 | 2 |
| GJT | Plasma, Coagulation Factor Deficient | 2 | 2 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| GIR | Reagent, Russel Viper Venom | 1 | 1 |
| GIS | Test, Fibrinogen | 1 | 1 |
| GJA | Test, Thrombin Time | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
Review panels
- Hematology (10)
Most recent R2 Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102908 | NOFACT IX | GJT | 2011-12-19 | 444 |
| K102851 | NOFACT VIII | GJT | 2011-12-19 | 446 |
| K090105 | LUPOTEK KCT | GGW | 2010-12-30 | 714 |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | GIR | 2010-06-25 | 543 |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | GGP | 2008-12-17 | 98 |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | GGC | 2007-03-16 | 220 |
| K050817 | T-TEK | GJA | 2005-12-12 | 256 |
| K042919 | FIBROTEK FIB | GIS | 2004-11-29 | 38 |
| K040296 | PHOSPHOPLASTIN RL | GJS | 2004-05-24 | 105 |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | GGW | 2004-02-04 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named R2 Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under R2 Diagnostics, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under R2 Diagnostics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “R2 Diagnostics, Inc.” (first 2004, latest 2011), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by R2 Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R2 Diagnostics, Inc. is 238 days.
Which FDA product codes appear under R2 Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are GGW (Test, Time, Partial Thromboplastin, 2); GJT (Plasma, Coagulation Factor Deficient, 2); GGC (Control, Plasma, Abnormal, 1).
Next steps
- See all 10 R2 Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGW, R2 Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.