Cleared Traditional

BD FACS SAMPLE PREP ASSISTANT III

K131301 · Becton, Dickinson & CO · Immunology
Aug 2013
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K131301 is an FDA 510(k) clearance for the BD FACS SAMPLE PREP ASSISTANT III, 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 August 2, 2013, 87 days after receiving the submission on May 7, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K131301 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2013
Decision Date August 02, 2013
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
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.