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FDA 510(k)

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

K-Number: K170854 · 2017-09-08

ApplicantInstrumentation Laboratory CO
Decision Date2017-09-08
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2017-09-08 under approval number K170854. 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 AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls?

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K170854.

When was HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls approved by the FDA?

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls received FDA 510(k) clearance on 2017-09-08, under approval number K170854.

What company makes HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls?

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls is manufactured by Instrumentation Laboratory CO.

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

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

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Related Devices (Code: LCO)

K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc. K201311PF4 IgG assayImmucor Gti Diagnostics, Inc. K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.

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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