Atlas FDA

DBM

27 FDA 510(k) clearances · Product code

69 daysmedian time to decision
264 days90th percentile
27clearances measured

FDA profile

Official device name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5090
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
EliA M2 Immunoassay (K181556)Phadia AB2018-07-13
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (K163525)Inova Diagnostics, Inc.2017-09-05
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA (K163133)Immco Diagnostics, Inc.2017-08-08
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (K141375)Phadia US, Inc.2015-02-13
EUROIMMUN ANTI-M2-3E ELISA (IGG) (K092736)Euroimmun Us, Inc.2010-09-02
QUANTA LITE M2 EP (MIT3) ELISA (K052262)Inova Diagnostics, Inc.2005-10-27
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (K031308)Rhigene, Inc.2003-09-26
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (K030238)The Binding Site, Ltd.2003-03-24
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (K982121)Trace Scientific , Ltd.1998-09-17
VIRGO AMA ELISA KIT (K971909)Hemagen Diagnostics, Inc.1997-06-20
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (K962452)Hycor Biomedical, Inc.1996-11-25
VARELISA M2 ANTIBODIES (K945607)Elias U.S.A., Inc.1995-01-24
MITOCHONDRIA EIA TEST KIT (K940251)David A. Fuccillo, Ph.D.1994-05-03
AYNELISA M2-ANTIBODIES (K930143)Elias U.S.A., Inc.1993-05-11
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT (K921183)Shield Diagnostics, Ltd.1992-06-19
AUTOFLUOR IV SYSTEM (K843181)Tech America Diagnostics1984-09-17
MELOY AUTOANTIBODY TEST SYS (K842247)Meloy Laboratories, Inc.1984-06-26
AUTOANTIBODY SCREEN TEST SYSTEM (K831358)Zeus Scientific, Inc.1983-06-15
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT (K831100)Medical Diagnostics, Ca.1983-05-04
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (K810984)Immuno-Products Industries1981-05-01
KALLESTAD HEP-2 CELL LINE SUBSTRATE (K810863)Kallestad Laboratories, Inc.1981-04-14
T/K (ATA/AMA) UNIVERSAL BIOPAK (K802308)Bioware Products1980-12-01
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY (K800821)Calbiochem-Behring Corp.1980-04-24
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT (K800229)Clinical Sciences, Inc.1980-02-21
TEST KIT, IIF-AMA (K790295)Medica Corp.1979-05-25
AFT SYSTEM (K771993)Calbiochem1977-11-02
TEST, (IVDP) MITOCHONDRIAL ANTIBODY (K760155)Zeus Scientific, Inc.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.