QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MI…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163525 FDA 510(k)
- FDA Product Code
- DBM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5090 FDA 510(k)
- Regulation Number
- 866.5090 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QUANTA Flash M2 (MIT3) is an Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control device used in immunology testing. It serves as calibrators and controls for laboratory diagnostic procedures to ensure accurate test results.
The device is supplied by Inova Diagnostics, Inc. and is authorized under FDA 510K clearance with product code DBM. It is regulated for use in immunology testing and is available in various sizes and model numbers as specified by the manufacturer.
Frequently asked questions
What is the QUANTA Flash M2 (MIT3) used for?
The QUANTA Flash M2 (MIT3) is an Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control device used in immunology testing. It serves as calibrators and controls for laboratory diagnostic procedures to ensure accurate test results.
How is the QUANTA Flash M2 (MIT3) supplied?
The device is supplied by Inova Diagnostics, Inc. and is available in various sizes and model numbers as specified by the manufacturer. It is authorized under FDA 510K clearance with product code DBM.
Is the QUANTA Flash M2 (MIT3) a single-use or reusable device?
The device description does not specify whether the QUANTA Flash M2 (MIT3) is single-use or reusable. For specific usage instructions regarding reprocessing or disposal, please refer to the manufacturer's documentation.
What is the regulatory status of the QUANTA Flash M2 (MIT3)?
The QUANTA Flash M2 (MIT3) is authorized under FDA 510K clearance with product code DBM and is regulated for use in immunology testing. It was received by the FDA on 2016-12-15 and cleared on 2017-09-05 with decision code SESE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163525 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA 510(k) K163525 24 fields · synced Sep 23, 2026