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Genalyte, Inc.
Genalyte, Inc.
Medical device manufacturer in San Diego, CA.
2
510(k) clearances
0
PMA approvals
0
recalls
Device types
LKO Anti-Rnp Antibody, Antigen And Control
1
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
1
510(k) clearances
510(k)
Device
Decision
K234091
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
JLW · Traditional
07/22/2024
SE
K191085
Maverick RNP Assay and Maverick Diagnostic System
LKO · Traditional
10/25/2019
SE