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Qbc Centrifugal Hematology Sys

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K830451

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830451 Date27 Apr 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GKL
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 QBC Centrifugal Hematology System is an automated cell counter used for hematology analysis. It is classified as a Class 2 medical device under FDA regulation 21 CFR 864.5200 and is designed for the automated counting and analysis of blood cells.

This device was cleared through the FDA 510(k) pathway under K830451 with a traditional clearance type and is substantially equivalent to a predicate device. It is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and is intended for use in clinical laboratory settings for hematology testing.

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