Medical Device Manufacturer · US , Lexington , MA

Instrumentation Laboratory - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Instrumentation Laboratory Hematology ✕
3 devices
1-3 of 3
Cleared Dec 29, 2023
ACL TOP 970 CL
K233790 · JPA
Hematology · 31d
Cleared Aug 15, 2014
HEMOSIL D-DIMER HS 500 CONTROL
K133582 · GGN
Hematology · 267d
Cleared Jul 31, 2008
HEMOSIL D-DIMER
K073042 · DAP
Hematology · 276d
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