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Coonan Clinical Labs

This article was originally published in The Tan Sheet

Executive Summary

Firm receives 510(k) marketing clearance for its blood sampling device intended for use in the company's home collection kit for HIV testing. While the device was initially submitted for clearance through "an affiliate company," Coonan maintains all marketing and ownership rights to the device, and says the 510(k) "clears the way" for the company to submit a premarket approval application for the entire home collection kit
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