Novapath TSH Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K903311 FDA 510(k)
- FDA Product Code
- JLW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1690 FDA 510(k)
- Regulation Number
- 862.1690 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novapath TSH Enzyme Immunoassay is a device intended to measure thyroid-stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. It functions as a radioimmunoassay thyroid-stimulating hormone test system.
This device is classified as a Class 2 medical device under regulation number 862.1690. It received FDA 510(k) clearance on September 7, 1990, under the product code JLW.
Frequently asked questions
What is the primary purpose of the Novapath TSH Enzyme Immunoassay?
This device is intended for the measurement of thyroid-stimulating hormone, also referred to as thyrotrophin or thyrotrophic hormone, within serum and plasma specimens.
How is this device classified for regulatory purposes?
The Novapath TSH Enzyme Immunoassay is classified as a Class 2 medical device under regulation number 862.1690, falling under the clinical chemistry advisory committee.
What is the regulatory history of this device?
The device received FDA 510(k) clearance on September 7, 1990, under the product code JLW, following a traditional submission process that determined it to be substantially equivalent to existing systems.
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: NOVAPATH TSH ENZYME IMMUNOASSAY (K903311) — FDA 510 (k) | Innolitics, Novapath Tsh Enzyme Immunoassay 510 (k) K903311 - FDA.report, PDF K903311 - Novapath Tsh Enzyme Immunoassay
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903311 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K903311 24 fields · synced Sep 23, 2026