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510(k) for PharmaNetics' thrombolytic assessment system supplements

This article was originally published in Clinica

Executive Summary

The US FDA has cleared PharmaNetics' electronic quality control test card and software upgrade for its thrombolytic assessment system (TAS). The reusable test card gives a three-level check to the TAS analyser as well as enhances the self-checks performed when the machine is initially switched on. According to the Raleigh, North Carolina-based company, the TAS software expands the menu of tests processed by the analyser and allows it to be linked to PharmaNetic's new Accent product which is currently awaiting FDA clearance.

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