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Instrumentation Laboratory CO

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories15
Latest FDA decision2023-09-29
TypeNumberDevice NameCodeDateActions
510(k) K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA2023-09-29 View
510(k) K223187 HemosIL Liquid Anti-XaQLU2023-06-23 View
510(k) K223090 GEM Premier ChemSTATCGA2023-01-27 View
510(k) K223402 HemosIL von Willebrand Factor AntigenGGP2022-12-09 View
510(k) K213464 HemosIL Liquid Anti-XaKFF2022-10-04 View
510(k) K213426 HemosIL ReadiPlasTinGJS2022-08-16 View
510(k) K203790 GEM Premier 5000CHL2021-08-20 View
510(k) K200033 HemosIL von Willebrand Factor AntigenGGP2020-08-19 View
510(k) K183549 GEM Premier ChemSTATJGS2019-02-16 View
510(k) K183555 GEM Premier ChemSTATJFY2019-02-16 View
510(k) K183546 GEM Premier ChemSTATCGA2019-02-16 View
510(k) K180486 HemosIL Factor XII Deficient PlasmaGJT2018-03-22 View
510(k) K173403 GEM Premier 5000CHL2017-12-29 View
510(k) K172903 HemosIL D-Dimer HS 500DAP2017-11-22 View
510(k) K170854 HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO2017-09-08 View
510(k) K170314 ACL AcuStarJPA2017-03-03 View
510(k) K160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorJGS2016-12-14 View
510(k) K160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)GKF2016-12-14 View
510(k) K160402 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)CGA2016-12-14 View
510(k) K160412 GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)CHL2016-12-14 View

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