Panels › Immunology › Product code DBM · Class 2
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5090
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in DBM
| Company | 510(k)s | Recalls |
|---|---|---|
| Elias U.S.A., Inc. | 2 | 0 |
| Inova Diagnostics, Inc. | 2 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Bio-Rad Laboratories | 0 | 1 |
| Bioware Products | 1 | 0 |
| Calbiochem | 1 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Clinical Sciences, Inc. | 1 | 0 |
| David A. Fuccillo, Ph.D. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2018 | K181556 | EliA M2 Immunoassay Phadia AB, SE | DBM |
| Sep 5, 2017 | K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls Inova Diagnostics, Inc. | DBM |
| Aug 8, 2017 | K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA Immco Diagnostics, Inc. | DBM |
| Feb 13, 2015 | K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 Phadia US, Inc., DE | DBM |
| Sep 2, 2010 | K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) Euroimmun Us, Inc. | DBM |
| Oct 27, 2005 | K052262 | QUANTA LITE M2 EP (MIT3) ELISA Inova Diagnostics, Inc. | DBM |
| Sep 26, 2003 | K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 Rhigene, Inc. | DBM |
| Mar 24, 2003 | K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT The Binding Site, Ltd. | DBM |
| Sep 17, 1998 | K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT Trace Scientific , Ltd. | DBM |
| Jun 20, 1997 | K971909 | VIRGO AMA ELISA KIT Hemagen Diagnostics, Inc. | DBM |
| Nov 25, 1996 | K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA Hycor Biomedical, Inc. | DBM |
| Jan 24, 1995 | K945607 | VARELISA M2 ANTIBODIES Elias U.S.A., Inc. | DBM |
| May 3, 1994 | K940251 | MITOCHONDRIA EIA TEST KIT David A. Fuccillo, Ph.D. | DBM |
| May 11, 1993 | K930143 | AYNELISA M2-ANTIBODIES Elias U.S.A., Inc. | DBM |
| Jun 19, 1992 | K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT Shield Diagnostics, Ltd., GB | DBM |
| Sep 17, 1984 | K843181 | AUTOFLUOR IV SYSTEM Tech America Diagnostics | DBM |
| Jun 26, 1984 | K842247 | MELOY AUTOANTIBODY TEST SYS Meloy Laboratories, Inc. | DBM |
| Jun 15, 1983 | K831358 | AUTOANTIBODY SCREEN TEST SYSTEM Zeus Scientific, Inc. | DBM |
| May 4, 1983 | K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT Medical Diagnostics, Ca. | DBM |
| May 1, 1981 | K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST Immuno-Products Industries | DBM |
| Apr 14, 1981 | K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE Kallestad Laboratories, Inc. | DBM |
| Dec 1, 1980 | K802308 | T/K (ATA/AMA) UNIVERSAL BIOPAK Bioware Products | DBM |
| Apr 24, 1980 | K800821 | AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY Calbiochem-Behring Corp. | DBM |
| Feb 21, 1980 | K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT Clinical Sciences, Inc. | DBM |
| May 25, 1979 | K790295 | TEST KIT, IIF-AMA Medica Corp. | DBM |
| Nov 2, 1977 | K771993 | AFT SYSTEM Calbiochem | DBM |
| Jul 20, 1976 | K760155 | TEST, (IVDP) MITOCHONDRIAL ANTIBODY Zeus Scientific, Inc. | DBM |
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