DeviceClearance

Product code PER— Clinical Chemistry

BD FACS SAMPLE PREP ASSISTANT III

Classification name
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device class
Class 1
Regulation
21 CFR 862.2750
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PER under 21 CFR 862.2750, via openFDA

Market context for product code PER

FDA has cleared 3 devices under product code PER between 2005 and 2013, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code PER

Recent clearances under product code PER

Data sourced from openFDA. This site is unofficial and independent of the FDA.