Identifiers
- 510(k) Number
- K926562 FDA 510(k)
- FDA Product Code
- LLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quanta Lite Jo-1 Elisa Kit is an extractable antinuclear antibody, antigen and control device. It is designed for use in immunological testing procedures.
This device is regulated under FDA 510k clearance. It is manufactured by Inova Diagnostics, Inc. and is classified as a class 2 medical device.
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
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K926562 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA 510(k) K926562 24 fields · synced Sep 23, 2026