
Genalyte, Inc.
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Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is an FDA 510(k)-cleared medical device (K234091) manufactured by Genalyte, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2024. Regulation: 8.