QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
FDA 510(k) K163525 · Inova Diagnostics, Inc.
510(k) numberK163525
Submission
- Device name
- QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- December 15, 2016
- Decision date
- September 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
| 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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| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
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Questions and answers
When was QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls cleared by the FDA?
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (K163525) received a 510(k) decision of Substantially Equivalent on September 5, 2017, 264 days after the submission was received.
What is the product code of K163525?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.