Identifiers
- 510(k) Number
- K904224 FDA 510(k)
- FDA Product Code
- JZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5870 FDA 510(k)
- Regulation Number
- 866.5870 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nova Lite Thyroid is a system test for thyroid autoantibody, classified under product code JZO and regulation number 866.5870. It is an in vitro diagnostic device used in immunology testing.
The device received FDA 510(k) clearance K904224 on October 15, 1990, as a substantially equivalent device under traditional review. It is manufactured by Inova Diagnostics, Inc. in San Diego, California, and is intended for use in laboratory settings for the detection of thyroid autoantibodies.
Frequently asked questions
What is the Nova Lite Thyroid used for?
The Nova Lite Thyroid is an in vitro diagnostic device used in immunology testing to detect thyroid autoantibodies in laboratory settings, as specified in its FDA 510(k) clearance.
How was the Nova Lite Thyroid cleared for market?
The device received FDA 510(k) clearance K904224 on October 15, 1990, through a traditional review process as a substantially equivalent device under product code JZO and regulation number 866.5870.
Who manufactures the Nova Lite Thyroid and where is it made?
The Nova Lite Thyroid is manufactured by Inova Diagnostics, Inc. at their facility located at 10451 Roselle St., San Diego, California, 92121, United States.
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. Sources consulted: NOVA LITE TM THYROID (K904224) — FDA 510 (k) | Innolitics, NOVA LITE TM THYROID (K904224) - FDA 510 (k), NOVA LITE TM THYROID 510 (k) K904224 - FDA.report, NOVA Lite® Thyroid - BEUDAMED, NOVA Lite | Werfen North America
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904224 | 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) K904224 24 fields · synced Sep 24, 2026