Class Class II

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (K250003)

K250003 2025-08-29 Traditional
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Description

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) by Geneseeq Technology, Inc., an FDA 510(k) cleared pathology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250003
Clearance Date2025-08-29
Clearance TypeTraditional
Product CodePZM
Regulation Number866.6080

Categories

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