Echoclonal Htsh Irma
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K860288 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 Echoclonal Htsh Irma is a radioimmunoassay device for measuring thyroid-stimulating hormone (TSH) levels. It is classified as a Class II medical device under product code JLW, with special controls applied. The device is designed for clinical laboratory use in thyroid function testing.
The Echoclonal Htsh Irma is manufactured by Bio-Rad and received FDA 510(k) clearance on April 11, 1986, with the K number K860288. It is supplied as a single-use device and requires appropriate storage conditions as specified by the manufacturer. The device is authorized for use in clinical chemistry laboratories.
Frequently asked questions
What is the Echoclonal Htsh Irma device used for?
The Echoclonal Htsh Irma is a radioimmunoassay device specifically designed for measuring thyroid-stimulating hormone (TSH) levels in clinical laboratory settings. It is used as part of thyroid function testing procedures.
Is the Echoclonal Htsh Irma a single-use device?
Yes, the Echoclonal Htsh Irma is supplied as a single-use device. This means it should be used for one testing procedure and then properly disposed of according to laboratory protocols and regulatory guidelines.
What is the regulatory classification of the Echoclonal Htsh Irma?
The Echoclonal Htsh Irma is classified as a Class II medical device under product code JLW with special controls. It received FDA 510(k) clearance on April 11, 1986, with K number K860288, and is authorized for use in clinical chemistry laboratories.
What are the storage requirements for the Echoclonal Htsh Irma?
The Echoclonal Htsh Irma requires appropriate storage conditions as specified by the manufacturer, Bio-Rad. Specific temperature ranges, humidity levels, and shelf life information should be obtained directly from the manufacturer's documentation or product insert.
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: ECHOCLONAL HTSH IRMA (K860288) — FDA 510 (k) | Innolitics, K860288 - ECHOCLONAL HTSH IRMA | FDA 510 (k) | Bio-Rad, Echoclonal Htsh Irma 510(k) K860288 - FDA.report, PDF K860288 - Echoclonal Htsh Irma, Bio-Rad Echoclonal (9601) - Thyroid stimulating hormone (TSH)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860288 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K860288 24 fields · synced Sep 28, 2026