NEW YORK (360Dx) – TearLab announced late on Wednesday that the US Food and Drug Administration has determined its point-of-care TearLab Discovery MMP-9 test failed to meet the criteria for substantial equivalence based on data and information in its 510(k) submission.

In order to get 510(k) clearance for a device, a company must show it is substantially equivalent to a similar device previously cleared by the FDA for marketing.

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