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Genalyte, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2024-07-22
TypeNumberDevice NameCodeDateActions
510(k) K234091 Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0JLW2024-07-22 View
510(k) K191085 Maverick RNP Assay and Maverick Diagnostic SystemLKO2019-10-25 View