HemosIL von Willebrand Factor Antigen
K-Number: K223402 · 2022-12-09
ApplicantInstrumentation Laboratory CO
Decision Date2022-12-09
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL von Willebrand Factor Antigen is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2022-12-09 under approval number K223402. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL von Willebrand Factor Antigen?
HemosIL von Willebrand Factor Antigen is a medical device that received FDA 510(k) clearance on 2022-12-09. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K223402.
When was HemosIL von Willebrand Factor Antigen approved by the FDA?
HemosIL von Willebrand Factor Antigen received FDA 510(k) clearance on 2022-12-09, under approval number K223402.
What company makes HemosIL von Willebrand Factor Antigen?
HemosIL von Willebrand Factor Antigen is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL von Willebrand Factor Antigen?
The FDA product code for HemosIL von Willebrand Factor Antigen is GGP.
Related Clinical Trials
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
Related Devices (Code: GGP)
K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH
K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc.
K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO
K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic
K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.
K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company
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.