Medical Device Manufacturer · US , Bedford , MA

Instrumentation Laboratory (IL) Co. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2024

Recent clearances: HemosIL Factor V Leiden (APC Resistance V), HemosIL Silica Clotting Time, HemosIL Fibrinogen-C

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Instrumentation Laboratory (IL) Co. Hematology ✕

5 devices

1-5 of 5

Cleared Mar 20, 2026

HemosIL Factor V Leiden (APC Resistance V)

Hematology · 30d

Cleared Jan 09, 2026

HemosIL Silica Clotting Time

Hematology · 30d

Cleared Jul 24, 2025

HemosIL Fibrinogen-C

Hematology · 28d

Cleared Jan 28, 2025

HemosIL CL HIT-IgG(PF4-H)

Hematology · 90d

Cleared Aug 16, 2024

ACL TOP Family 50 Series (ACL TOP 750

Hematology · 28d