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Genalyte, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0July 22, 2024
K191085Maverick RNP Assay and Maverick Diagnostic SystemOctober 25, 2019