www.fdanews.com/articles/178792-fda-approves-lbts-automated-plate-assessment-system
FDA Approves LBT's Automated Plate Assessment System
October 10, 2016
Clever Culture Systems AG has received marketing clearance of a 510(k) de novo submission to the FDA for its Automated Plate Assessment System (APAS) as a Class II medical device.
The device system uses a technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation. — Cynthia Jessup