Medical Device Manufacturer · US , Mchenry , IL

Medica Corp.

47 submissions · 47 cleared · Since 1979
47
Total
47
Cleared
0
Denied

Medica Corp. — FDA 510(k) Submissions

Medica Corp. has submitted 47 FDA 510(k) premarket notifications since 1979, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Ion Specific, Sodium, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Diazo Colorimetry, Bilirubin, Electrode, Ion Specific, Potassium, Electrode, Ion-specific, Chloride . Use the specialty filter in the sidebar to narrow results.

47 devices
1–25 of 47
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Mar 2013 81d
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · LCP Assay, Glycosylated... · Chemistry
May 2012 83d
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
K111363 · JXN Enzyme Immunoassay,... · Chemistry
Dec 2011 204d
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · DIC Alcohol Dehydrogenase,... · Toxicology
Nov 2011 218d
EASTLYTE NA/K/CA/PH
K112788 · CEM Electrode, Ion Specific,... · Chemistry
Oct 2011 24d
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
K101089 · DCF Albumin, Antigen,... · Chemistry
Jul 2011 450d
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · CJE Nitrophenylphosphate,... · Chemistry
May 2011 396d
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675 · CDQ Urease And Glutamic... · Chemistry
Apr 2011 42d
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
K101088 · CIX Bromcresol Green... · Chemistry
Apr 2011 350d
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829 · JGS Electrode, Ion Specific,... · Chemistry
Jan 2011 296d
EASYCELL CELL LOCATOR
K092116 · JOY Device, Automated... · Hematology
May 2010 302d
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
K100187 · CGA Glucose Oxidase, Glucose · Chemistry
May 2010 103d
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · JGS Electrode, Ion Specific,... · Chemistry
Apr 2010 28d
EASYRA MG REAGENT, MODEL 10220
K092737 · JGJ Photometric Method,... · Chemistry
Nov 2009 70d
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · CFR Hexokinase, Glucose · Chemistry
Sep 2009 30d
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Sep 2009 64d
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
K090734 · MRR System, Test, Low... · Chemistry
Jul 2009 120d
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
K080404 · JIX Calibrator, Multi-analyte... · Chemistry
Mar 2009 393d
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
K080874 · CIX Bromcresol Green... · Chemistry
Feb 2009 326d
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
K080810 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Dec 2008 264d
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · JFJ Catalytic Methods, Amylase · Chemistry
Nov 2008 238d
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · LBS Ldl & Vldl Precipitation,... · Chemistry
Apr 2008 123d
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
K072249 · CHH Enzymatic... · Chemistry
Feb 2008 191d
EASYRA CLINICAL CHEMISTRY ANALYZER
K070057 · CGA Glucose Oxidase, Glucose · Chemistry
Aug 2007 237d
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
K063376 · CHL Electrode Measurement,... · Chemistry
Jun 2007 229d
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