510(k) K163525
- Device
- QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- Applicant
- Inova Diagnostics, Inc.
- 510(k) number
- K163525
- Product code
- DBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-05
- Date received
- 2016-12-15
- 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
- No
Applicant Contact#
- Contact
- Peter Martis
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 8043792
- 2026994
- 3007361513
- 3003268355
- 3012348571
- 1318354
- 3032705
- 2242436
- 2029372
- 3004973408
- 9610566
- 1181055
- 3007118747
- 2915274
- 9616003
Source Documents#
Other 510(k) Records For Product Code DBM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181556 | EliA M2 Immunoassay | Phadia AB | 2018-07-13 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | 2017-08-08 |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | 2015-02-13 |
| K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | Euroimmun Us, Inc. | 2010-09-02 |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | 2005-10-27 |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Rhigene, Inc. | 2003-09-26 |
| K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | The Binding Site, Ltd. | 2003-03-24 |
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | 1998-09-17 |
| K971909 | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | 1997-06-20 |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | 1996-11-25 |
| K945607 | VARELISA M2 ANTIBODIES | Elias U.S.A., Inc. | 1995-01-24 |
| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-03 |
| K930143 | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | 1992-06-19 |
| K843181 | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | 1984-09-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary