Corgenix, Inc.: FDA clearances and approvals
Corgenix, Inc. has 23 FDA 510(k) clearances (first 1998, latest 2008), across 7 product codes in 2 review panels. Median 510(k) review time: 35 days.
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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 8 | 8 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 8 | 8 |
| DHC | System, Test, Systemic Lupus Erythematosus | 2 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| OBW | 11-Dehydro Thromboxane B2 Kit, Urinary | 1 | 1 |
Review panels
- Immunology (20)
- Hematology (3)
Most recent Corgenix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072032 | IGG ANTI-ATHEROX TEST KIT | MSV | 2008-04-04 | 255 |
| K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | OBW | 2007-05-29 | 315 |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | DHN | 2004-11-19 | 51 |
| K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | GGP | 2004-04-05 | 269 |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | LKJ | 2004-01-08 | 15 |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | MID | 2003-10-14 | 29 |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | MSV | 2003-07-07 | 81 |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | MID | 2003-01-03 | 14 |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | MID | 2003-01-03 | 14 |
| K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | MID | 2002-09-25 | 16 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Corgenix, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Corgenix, Inc. have?
Corgenix, Inc. has 23 FDA 510(k) clearances (first 1998, latest 2008), across 7 product codes in 2 review panels.
How long does FDA take to clear Corgenix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Corgenix, Inc.'s cleared 510(k)s is 35 days.
What devices does Corgenix, Inc. make?
Its most frequent FDA product codes are MID (System, Test, Anticardiolipin Immunological, 8); MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), 8); DHC (System, Test, Systemic Lupus Erythematosus, 2).
Has Corgenix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Corgenix, Inc. Related entities may recall under other names.
Next steps
- See all 23 Corgenix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MID, Corgenix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.