In Brief: AccuMed
This article was originally published in The Gray Sheet
AccuMed: Files 510(k) Jan. 29 to add the use of monolayer (liquid-based preparation) cytology specimens to the existing claims for the intended use of its TracCell 2000 slide mapping system when used with AccuMed's AcCell workstation. The TracCell currently is indicated for use with Pap smear slides. Separately, AccuMed receives 510(k) clearance to market its Sensititre gram positive identification panel for use in conjunction with the Sensititre microbiology system for the automated identification of clinically significant gram positive bacteria, the firm says...
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