Rhigene, Inc.
Des Plaines, IL, US
Rhigene, Inc. appears in FDA device records in Des Plaines, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Rhigene, Inc. between 2000 and 2004. The busiest year on record is 2000, with 7. The most recent is 2004, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 7 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040711 | MESACUP TEST PR-3 | MOB | Substantially Equivalent | |
| K040586 | MESACUP TEST MPO, MODEL 11053 | MOB | Substantially Equivalent | |
| K040200 | MESACUP-2 TEST CENP-B | LJM | Substantially Equivalent | |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | LLL | Substantially Equivalent | |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | DBM | Substantially Equivalent | |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | LKO | Substantially Equivalent | |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | LJM | Substantially Equivalent | |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | KTL | Substantially Equivalent | |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | NBO | Substantially Equivalent | |
| K000755 | RHIGENE MESACUP2 TEST- SM | LKP | Substantially Equivalent | |
| K000752 | RHIGENE MESACUP2 TEST- RNP | LKO | Substantially Equivalent | |
| K000751 | RHIGENE MESACUP2 TEST- SSB | LLL | Substantially Equivalent | |
| K000750 | RHIGENE MESACUP2 TEST- SCL-70 | LLL | Substantially Equivalent | |
| K000749 | RHIGENE MESACUP2 TEST- SSA | LLL | Substantially Equivalent | |
| K994071 | RHIGENE ANA ELISA TEST SYSTEM | LJM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
- LLLExtractable Antinuclear Antibody, Antigen And Control
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Rhigene, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Rhigene, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain