DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Class II
FDA product code DBM covers "Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control", a Class II medical device regulated under 21 CFR 866.5090. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DBM
- Device Class
- Class II
- Regulation Number
- 866.5090
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181556 | phadia | EliA M2 Immunoassay | July 13, 2018 |
| K163525 | inova diagnostics | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT | September 5, 2017 |
| K163133 | immco diagnostics | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti | August 8, 2017 |
| K141375 | phadia us | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | February 13, 2015 |
| K092736 | euroimmun us | EUROIMMUN ANTI-M2-3E ELISA (IGG) | September 2, 2010 |
| K052262 | inova diagnostics | QUANTA LITE M2 EP (MIT3) ELISA | October 27, 2005 |
| K031308 | rhigene | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | September 26, 2003 |
| K030238 | binding site | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | March 24, 2003 |
| K982121 | trace scientific | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | September 17, 1998 |
| K971909 | hemagen diagnostics | VIRGO AMA ELISA KIT | June 20, 1997 |
| K962452 | hycor biomedical | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | November 25, 1996 |
| K945607 | elias u.s.a | VARELISA M2 ANTIBODIES | January 24, 1995 |
| K940251 | david a. fuccillo, ph.d | MITOCHONDRIA EIA TEST KIT | May 3, 1994 |
| K930143 | elias u.s.a | AYNELISA M2-ANTIBODIES | May 11, 1993 |
| K921183 | shield diagnostics | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | June 19, 1992 |
| K843181 | tech america diagnostics | AUTOFLUOR IV SYSTEM | September 17, 1984 |
| K842247 | meloy laboratories | MELOY AUTOANTIBODY TEST SYS | June 26, 1984 |
| K831358 | zeus scientific | AUTOANTIBODY SCREEN TEST SYSTEM | June 15, 1983 |
| K831100 | medical diagnostics, ca | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | May 4, 1983 |
| K810984 | immuno-products industries | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | May 1, 1981 |