FDA 510(k) Applications for Medical Device Product Code "DBM"
(Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K092736 | EUROIMMUN US INC | EUROIMMUN ANTI-M2-3E ELISA (IGG) | 09/02/2010 |
| K971909 | HEMAGEN DIAGNOSTICS, INC. | VIRGO AMA ELISA KIT | 06/20/1997 |
| K962452 | HYCOR BIOMEDICAL, INC. | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | 11/25/1996 |
| K163133 | IMMCO Diagnostics, Inc. | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | 08/08/2017 |
| K163525 | Inova Diagnostics, Inc. | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | 09/05/2017 |
| K052262 | INOVA DIAGNOSTICS, INC. | QUANTA LITE M2 EP (MIT3) ELISA | 10/27/2005 |
| K181556 | Phadia AB | EliA M2 Immunoassay | 07/13/2018 |
| K141375 | PHADIA US INC. | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | 02/13/2015 |
| K031308 | RHIGENE, INC. | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | 09/26/2003 |
| K030238 | THE BINDING SITE, LTD. | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | 03/24/2003 |
| K982121 | TRACE SCIENTIFIC LTD. | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | 09/17/1998 |
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