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TFR

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981208

by Ramco Laboratories, Inc.

Identifiers

510(k) Number
K981208 FDA 510(k)
FDA Product Code
JNM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5880 FDA 510(k)
Regulation Number
866.5880 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TFR is an immunochemical device used for the determination of serum transferrin receptor. It is a Class 2 medical device with product code JNM, manufactured by Ramco Laboratories, Inc.

The device is supplied as part of an ELISA test kit for laboratory use. It received FDA 510(k) clearance through the Traditional pathway on October 21, 1998, with decision code SESE, indicating it is substantially equivalent to predicate devices. The device is regulated under number 866.5880 and is intended for immunology applications.

Frequently asked questions

What clinical purpose does the TFR device serve?

TFR is used to determine the concentration of serum transferrin receptor, an immunochemical marker useful in assessing iron status and related disorders in laboratory immunology testing.

How is the TFR device supplied to the user?

The device is provided as part of a complete ELISA test kit designed for laboratory use, allowing the user to perform the assay without needing additional components.

Is the TFR kit intended for single‑use or can it be reused?

The ELISA kit, including the TFR reagents, is intended for single‑use per patient sample to maintain assay integrity and avoid cross‑contamination; the kit components are not designed for reuse.

What regulatory pathway was used for the TFR device’s clearance?

TFR received FDA 510(k) clearance through the Traditional pathway on October 21, 1998, with a decision code indicating it is substantially equivalent to existing predicate devices.

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: K981208 FDA 510 (k) - TFR | Ramco Laboratories, Inc., Ramco Laboratories, Inc. FDA 510 (k) Products (1981-1998), TFR 510 (k) K981208 - FDA.report, Evaluation of an ELISA test for determination of the serum transferrin ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ramco Laboratories, Inc.

Sources (1)

  • FDA 510(k) K981208 24 fields · synced Sep 24, 2026