Cleared Special

MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE

K050191 · Becton, Dickinson & CO · Hematology
Feb 2005
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K050191 is an FDA 510(k) clearance for the MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE, a Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (Class I — General Controls, product code PER), submitted by Becton, Dickinson & CO (San Jose, US). The FDA issued a Cleared decision on February 22, 2005, 26 days after receiving the submission on January 27, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K050191 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2005
Decision Date February 22, 2005
Days to Decision 26 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750
Definition Flow Cytometer Specimen Processors Are Automated Or Semi-automated Workstations Designed To Be Used Alone Or In Combination With Manual Methods To Pipette, Dilute And Process Human Specimens In Preparation For Flow Cytometric Analysis.