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FDA grants 510(k) clearance to Targeted Genomics’ GlutenID test
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Targeted Genomics’ GlutenID test, designed to ...
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510(k) clearance issued by FDA for the VIA360 Surgical System by New World Medical
New World Medical received 510 (k) clearance from the US Food and Drug Administration (FDA) for its VIA360 Surgical System ...
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LetsGetChecked Lancing Device Nabs FDA 510(k) Clearance
Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single-use blood ...
Hologic announces FDA clearance of Aptima SARS-CoV-2 assay
Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency ...