Cleared Traditional

TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION

K130253 · Beckman Coulter, Inc. · Immunology
Jul 2013
Decision
164d
Days
Class 1
Risk

About This 510(k) Submission

K130253 is an FDA 510(k) clearance for the TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION, a Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (Class I — General Controls, product code PER), submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 15, 2013, 164 days after receiving the submission on February 1, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K130253 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2013
Decision Date July 15, 2013
Days to Decision 164 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.