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Genalyte, Inc.

FDA Regulatory Profile

Genalyte, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 22, 2024.

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

FDA data resources