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Immuno Ra Undiluted

FDA 510(k)

Class II (US FDA 510(k))

510(k) K926569

by Immunostics Co., Inc.

Identifiers

510(k) Number
K926569 FDA 510(k)
FDA Product Code
DHR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5775 FDA 510(k)
Regulation Number
866.5775 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Immuno Ra Undiluted is a System, Test, Rheumatoid Factor device classified under immunology. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

The device was cleared by the FDA on April 6, 1993, under k-number K926569. It is manufactured by Immunostics Co., Inc. and is intended for use in immunology testing.

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: IMMUNO RA UNDILUTED (K926569) — FDA 510 (k) | Innolitics, FDA Browser - Cleared 510 (K) - IMMUNO RA UNDILUTED (K926569), Immunostics Co Inc FDA Filings, Home | immunostics, Immunostics-Co FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunostics Co., Inc.

Sources (1)

  • FDA 510(k) K926569 24 fields · synced Sep 19, 2026