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Biomerieux Hemolab At III

by Biomerieux Vitek, Inc.

510(k) K934156

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 NumberK934156 Date22 Dec 1994ClearedStatusActive

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  • Withdrawn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
JBQ
Device Class
Class II
Regulation
21 CFR Part 864.7060
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Biomerieux Hemolab At III is an antithrombin III quantitation device used in hematology testing. It is a substantially equivalent device cleared through the FDA 510(k) process under product code JBQ and regulation number 864.7060.

The device is manufactured by Biomerieux Vitek, Inc. and was cleared via traditional 510(k) submission K934156 on December 22, 1994. It is intended for use in clinical laboratory settings for the quantification of antithrombin III as part of hematology diagnostics.

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Questions

AI-generated answers, 6 Oct 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 Biomerieux Hemolab At III used for?

    The Biomerieux Hemolab At III is used for the quantification of antithrombin III as part of hematology diagnostics in clinical laboratory settings, enabling measurement of this protein involved in blood coagulation regulation.

  • How was the Biomerieux Hemolab At III cleared for market?

    The device was cleared through the FDA 510(k) process as substantially equivalent under product code JBQ and regulation number 864.7060, based on traditional submission K934156 received on August 27, 1993 and cleared on December 22, 1994.

  • Who manufactures the Biomerieux Hemolab At III and where is it located?

    Biomerieux Vitek, Inc. manufactures the device, with its address listed as 595 Anglum Dr., Hazelwood, MO 63042, United States, as indicated in the device registration and submission records.