PER · Class I · 21 CFR 862.2750

FDA Product Code PER: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

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.

Leading manufacturers include Becton, Dickinson & CO and Beckman Coulter, Inc..

3
Total
3
Cleared
92d
Avg days
2005
Since

FDA 510(k) Cleared Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis Devices (Product Code PER)

3 devices
1–3 of 3
Cleared Aug 02, 2013
BD FACS SAMPLE PREP ASSISTANT III
K131301
Becton, Dickinson & CO
Immunology · 87d
Cleared Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
K130253
Beckman Coulter, Inc.
Immunology · 164d
Cleared Feb 22, 2005
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
K050191
Becton, Dickinson & CO
Hematology · 26d

About Product Code PER - Regulatory Context