FDA.reportPublic FDA data

510(k) K031308

Device
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
Applicant
Rhigene, Inc.
510(k) number
K031308
Product code
DBM
Decision
Substantially Equivalent (SESE)
Decision date
2003-09-26
Date received
2003-04-24
Regulation
866.5090
Classification name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
NANCI DEXTER
Address
12061 Tejon St. Westminster CO US 80234 80234

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DBM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181556EliA M2 ImmunoassayPhadia AB2018-07-13
K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.2017-09-05
K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.2017-08-08
K141375ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250Phadia US, Inc.2015-02-13
K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.2010-09-02
K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.2005-10-27
K030238BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KITThe Binding Site, Ltd.2003-03-24
K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTTrace Scientific , Ltd.1998-09-17
K971909VIRGO AMA ELISA KITHemagen Diagnostics, Inc.1997-06-20
K962452HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIAHycor Biomedical, Inc.1996-11-25
K945607VARELISA M2 ANTIBODIESElias U.S.A., Inc.1995-01-24
K940251MITOCHONDRIA EIA TEST KITDavid A. Fuccillo, Ph.D.1994-05-03
K930143AYNELISA M2-ANTIBODIESElias U.S.A., Inc.1993-05-11
K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITShield Diagnostics, Ltd.1992-06-19
K843181AUTOFLUOR IV SYSTEMTech America Diagnostics1984-09-17