Quanta Lite M2 Ep (MIT3) Elisa
FDA 510(k) K052262 · Inova Diagnostics, Inc.
510(k) numberK052262
Submission
- Device name
- Quanta Lite M2 Ep (MIT3) Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- August 19, 2005
- Decision date
- October 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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|---|---|---|---|
| K181556 | EliA M2 ImmunoassayDBM · Traditional | Phadia AB | 07/13/2018SE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…DBM · Traditional | Inova Diagnostics, Inc. | 09/05/2017SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | Immco Diagnostics, Inc. | 08/08/2017SE |
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | Phadia US, Inc. | 02/13/2015SE |
| K092736 | Euroimmun ANTI-M2-3E Elisa (Igg)DBM · Traditional | Euroimmun Us, Inc. | 09/02/2010SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | Rhigene, Inc. | 09/26/2003SE |
| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | The Binding Site, Ltd. | 03/24/2003SE |
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | Trace Scientific , Ltd. | 09/17/1998SE |
| K971909 | Virgo Ama Elisa KitDBM · Traditional | Hemagen Diagnostics, Inc. | 06/20/1997SE |
| K962452 | Hy-Tec/Manual Autoimmune Kit for MitochondriaDBM · Traditional | Hycor Biomedical, Inc. | 11/25/1996SE |
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| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
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Questions and answers
When was Quanta Lite M2 Ep (MIT3) Elisa cleared by the FDA?
Quanta Lite M2 Ep (MIT3) Elisa (K052262) received a 510(k) decision of Substantially Equivalent on October 27, 2005, 69 days after the submission was received.
What is the product code of K052262?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.