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FDA 510(k)

HemosIL CL HIT-IgG(PF4-H)

K-Number: K243374 · 2025-01-28

ApplicantInstrumentation Laboratory (IL) Co.
Decision Date2025-01-28
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL CL HIT-IgG(PF4-H) is a medical device manufactured by Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2025-01-28 under approval number K243374. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL CL HIT-IgG(PF4-H)?

HemosIL CL HIT-IgG(PF4-H) is a medical device that received FDA 510(k) clearance on 2025-01-28. It is manufactured by Instrumentation Laboratory (IL) Co.. The 510(k) number is K243374.

When was HemosIL CL HIT-IgG(PF4-H) approved by the FDA?

HemosIL CL HIT-IgG(PF4-H) received FDA 510(k) clearance on 2025-01-28, under approval number K243374.

What company makes HemosIL CL HIT-IgG(PF4-H)?

HemosIL CL HIT-IgG(PF4-H) is manufactured by Instrumentation Laboratory (IL) Co..

What is the FDA product code for HemosIL CL HIT-IgG(PF4-H)?

The FDA product code for HemosIL CL HIT-IgG(PF4-H) is LCO.

Other Devices by Instrumentation Laboratory (IL) Co.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL K260551HemosIL Factor V Leiden (APC Resistance V) K253957HemosIL Silica Clotting Time

Related Devices (Code: LCO)

K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc. K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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