Rhigene, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Rhigene, Inc.” (first 2000, latest 2004), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 4 | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 3 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | 1 | 1 |
Review panels
- Immunology (15)
Most recent Rhigene, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040711 | MESACUP TEST PR-3 | MOB | 2004-04-02 | 15 |
| K040586 | MESACUP TEST MPO, MODEL 11053 | MOB | 2004-03-22 | 17 |
| K040200 | MESACUP-2 TEST CENP-B | LJM | 2004-03-04 | 35 |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | LLL | 2003-12-22 | 45 |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | DBM | 2003-09-26 | 155 |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | LKO | 2002-08-14 | 55 |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | LJM | 2002-07-05 | 15 |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | KTL | 2002-04-11 | 367 |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | NBO | 2000-06-09 | 127 |
| K000755 | RHIGENE MESACUP2 TEST- SM | LKP | 2000-05-09 | 62 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rhigene, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rhigene, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Rhigene, Inc.” (first 2000, latest 2004), 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 Rhigene, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rhigene, Inc. is 62 days.
Which FDA product codes appear under Rhigene, Inc.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 4); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 3); LKO (Anti-Rnp Antibody, Antigen And Control, 2).
Next steps
- See all 15 Rhigene, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Rhigene, 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.