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
K802308 BIOWARE PRODUCTS T/K (ATA/AMA) UNIVERSAL BIOPAK 12/01/1980
K771993 CALBIOCHEM AFT SYSTEM 11/02/1977
K800821 CALBIOCHEM-BEHRING CORP. AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY 04/24/1980
K800229 CLINICAL SCIENCES, INC. IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT 02/21/1980
K940251 DAVID A. FUCCILLO, PH.D. MITOCHONDRIA EIA TEST KIT 05/03/1994
K930143 ELIAS USA, INC. AYNELISA M2-ANTIBODIES 05/11/1993
K945607 ELIAS USA, INC. VARELISA M2 ANTIBODIES 01/24/1995
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
K810984 IMMUNO-PRODUCTS INDUSTRIES ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST 05/01/1981
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
K810863 KALLESTAD LABORATORIES, INC. KALLESTAD HEP-2 CELL LINE SUBSTRATE 04/14/1981
K790295 MEDICA CORP. TEST KIT, IIF-AMA 05/25/1979
K831100 MEDICAL DIAGNOSTICS, CA. MEDICA IIF-MULTIPLE ANTIBODY TEST KIT 05/04/1983
K842247 MELOY LABORATORIES, INC. MELOY AUTOANTIBODY TEST SYS 06/26/1984
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
K921183 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT 06/19/1992
K843181 TECH AMERICA DIAGNOSTICS AUTOFLUOR IV SYSTEM 09/17/1984
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
K831358 ZEUS SCIENTIFIC, INC. AUTOANTIBODY SCREEN TEST SYSTEM 06/15/1983
K760155 ZEUS SCIENTIFIC, INC. TEST, (IVDP) MITOCHONDRIAL ANTIBODY 07/20/1976


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