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Medical Devices / Submissions and Approvals

FDA Approves LBT's Automated Plate Assessment System

Oct. 11, 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

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