Company ยท US
Rhigene, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2004. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2004 | K040711 | MESACUP TEST PR-3 Rhigene, Inc. | MOB |
| Mar 22, 2004 | K040586 | MESACUP TEST MPO, MODEL 11053 Rhigene, Inc. | MOB |
| Mar 4, 2004 | K040200 | MESACUP-2 TEST CENP-B Rhigene, Inc. | LJM |
| Dec 22, 2003 | K033528 | MESACUP-2 TEST JO-1, MODEL 10756 Rhigene, Inc. | LLL |
| Sep 26, 2003 | K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 Rhigene, Inc. | DBM |
| Aug 14, 2002 | K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 Rhigene, Inc. | LKO |
| Jul 5, 2002 | K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 Rhigene, Inc. | LJM |
| Apr 11, 2002 | K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L Rhigene, Inc. | KTL |
| Jun 9, 2000 | K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E Rhigene, Inc. | NBO |
| May 9, 2000 | K000755 | RHIGENE MESACUP2 TEST- SM Rhigene, Inc. | LKP |
| May 9, 2000 | K000752 | RHIGENE MESACUP2 TEST- RNP Rhigene, Inc. | LKO |
| May 9, 2000 | K000751 | RHIGENE MESACUP2 TEST- SSB Rhigene, Inc. | LLL |
| May 9, 2000 | K000750 | RHIGENE MESACUP2 TEST- SCL-70 Rhigene, Inc. | LLL |
| May 9, 2000 | K000749 | RHIGENE MESACUP2 TEST- SSA Rhigene, Inc. | LLL |
| Jan 18, 2000 | K994071 | RHIGENE ANA ELISA TEST SYSTEM Rhigene, Inc. | LJM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||