Cleared Special

QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM

K992849 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology
Sep 1999
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K992849 is an FDA 510(k) clearance for the QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on September 23, 1999, 30 days after receiving the submission on August 24, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K992849 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1999
Decision Date September 23, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220