Identifiers
- 510(k) Number
- K950090 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 Orgentec Anti-Tpo Pia is a System, Test, Thyroid Autoantibody device. It is classified as a device with a product code of JZO and is used in the medical specialty of Immunology. The device is substantially equivalent to other devices on the market.
The device has an FDA 510K clearance with the number K950090 and is regulated under regulation number 866.5870. It was cleared on April 21, 1995, and has a device class of 2. The device is supplied by American Laboratory Products Co., Ltd.
Frequently asked questions
What is the Orgentec Anti-Tpo Pia used for?
The Orgentec Anti-Tpo Pia is used to test for thyroid autoantibodies in the medical specialty of Immunology.
Is the Orgentec Anti-Tpo Pia cleared by the FDA?
Yes, the Orgentec Anti-Tpo Pia has an FDA 510K clearance with the number K950090, indicating it is substantially equivalent to other devices on the market.
What is the product code of the Orgentec Anti-Tpo Pia?
The product code of the Orgentec Anti-Tpo Pia is JZO, which is a classification for devices used in immunology.
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: ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950090) — FDA 510 (k ..., Orgentec Anti-tg/Anti-tpo Pia (Pin Immuno Assay), ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) 510(k) K950090 - fda.report, api.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950090 | Class II | Active |
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Manufacturer
- Manufacturer
- American Laboratory Products Co., Ltd.
Sources (1)
- FDA 510(k) K950090 24 fields · synced Oct 1, 2026