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Truquant Br Ria

by Biomira USA, Inc.

510(k) K965141

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK965141 Date31 Oct 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MOI
Device Class
Class II
Regulation
21 CFR Part 866.6010
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Truquant Br Ria is a system, test, immunological, antigen, tumor device. It is classified as a class 2 device. The device is used in the field of immunology.

The Truquant Br Ria is supplied with a product code of MOI and a regulation number of 866.6010. It has been cleared by the FDA with a 510(k) clearance, specifically K965141. The device is intended for use in immunological testing.

Other devices from Biomira, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Truquant Br Ria used for?

    The Truquant Br Ria is used for immunological testing, specifically for antigen tumor testing in the field of immunology.

  • How is the Truquant Br Ria supplied?

    The Truquant Br Ria is supplied with a product code of MOI and a regulation number of 866.6010.

  • Is the Truquant Br Ria cleared by the FDA?

    Yes, the Truquant Br Ria has been cleared by the FDA with a 510(k) clearance, specifically K965141, indicating it is substantially equivalent to a predicate device.