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FDA 510(k)

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

K-Number: K153137 · 2016-07-08

ApplicantInstrumentation Laboratory CO
Decision Date2016-07-08
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-07-08 under approval number K153137. 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 HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K153137.

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

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls received FDA 510(k) clearance on 2016-07-08, under approval number K153137.

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

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

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

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

Other Devices by Instrumentation Laboratory CO

K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160885HemosIL D-Dimer HS K161818GEM Premier 3000

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Related Devices (Code: LCO)

K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT 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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