Medical Device Manufacturer · US , Mchenry , IL

Instrumentation Laboratory CO

321 submissions · 320 cleared · Since 1976
321
Total
320
Cleared
1
Denied

Instrumentation Laboratory CO — FDA 510(k) Submissions

Instrumentation Laboratory CO has submitted 321 FDA 510(k) premarket notifications since 1976, of which 320 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Qualitative And Quantitative Factor Deficiency, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Test, Time, Prothrombin, System, Multipurpose For In Vitro Coagulation Studies, Plasma, Coagulation Factor Deficient . Use the specialty filter in the sidebar to narrow results.

321 devices
1–25 of 321
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-?2 Glycoprotein-I IgM
K221359 · JPA System, Multipurpose For... · Hematology
Sep 2023 506d
HemosIL Liquid Anti-Xa
K223187 · QLU Anti-factor Xa Activity... · Hematology
Jun 2023 254d
GEM Premier ChemSTAT
K223090 · CGA Glucose Oxidase, Glucose · Chemistry
Jan 2023 119d
HemosIL von Willebrand Factor Antigen
K223402 · GGP Test, Qualitative And... · Hematology
Dec 2022 30d
HemosIL Liquid Anti-Xa
K213464 · KFF Assay, Heparin · Hematology
Oct 2022 341d
HemosIL ReadiPlasTin
K213426 · GJS Test, Time, Prothrombin · Hematology
Aug 2022 299d
GEM Premier 5000
K203790 · CHL Electrode Measurement,... · Chemistry
Aug 2021 235d
HemosIL Liquid Anti-Xa
DEN190032 · QLU Anti-factor Xa Activity... · Hematology
Sep 2020 450d
HemosIL von Willebrand Factor Antigen
K200033 · GGP Test, Qualitative And... · Hematology
Aug 2020 225d
GEM Premier ChemSTAT
K183546 · CGA Glucose Oxidase, Glucose · Chemistry
Feb 2019 58d
GEM Premier ChemSTAT
K183549 · JGS Electrode, Ion Specific,... · Chemistry
Feb 2019 58d
GEM Premier ChemSTAT
K183555 · JFY Enzymatic Method, Creatinine · Chemistry
Feb 2019 58d
HemosIL Factor XII Deficient Plasma
K180486 · GJT Plasma, Coagulation... · Hematology
Mar 2018 27d
GEM Premier 5000
K173403 · CHL Electrode Measurement,... · Chemistry
Dec 2017 59d
HemosIL D-Dimer HS 500
K172903 · DAP Fibrinogen And Fibrin... · Hematology
Nov 2017 61d
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · LCO Platelet Factor 4... · Hematology
Sep 2017 170d
ACL AcuStar
K170314 · JPA System, Multipurpose For... · Hematology
Mar 2017 30d
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
K160225 · JGS Electrode, Ion Specific,... · Chemistry
Dec 2016 320d
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · CGA Glucose Oxidase, Glucose · Chemistry
Dec 2016 306d
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL Electrode Measurement,... · Chemistry
Dec 2016 306d
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415 · GKF Instrument, Hematocrit,... · Chemistry
Dec 2016 306d
HemosIL D-Dimer HS
K160885 · DAP Fibrinogen And Fibrin... · Hematology
Oct 2016 210d
GEM Premier 3000
K161818 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2016 75d
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137 · LCO Platelet Factor 4... · Hematology
Jul 2016 252d
HemosIL Silica Clotting Time
K160445 · GFO Activated Partial... · Hematology
Mar 2016 28d

Looking for a specific device from Instrumentation Laboratory CO? Search by device name or K-number.

Search all Instrumentation... devices
Filters