FDA 510(k) Applications Submitted by Photios Makris

FDA 510(k) Number Submission Date Device Name Applicant
K070057 01/05/2007 EASYRA CLINICAL CHEMISTRY ANALYZER MEDICA CORP.
K130080 01/14/2013 EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL MEDICA CORPORATION
K100187 01/22/2010 EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT MEDICA CORP.
K220396 02/11/2022 EasyStat 300 Medica corporation
K080404 02/14/2008 EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR MEDICA CORP.
K120497 02/21/2012 EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL MEDICA CORP.
K100673 03/09/2010 EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 MEDICA CORP.
K110675 03/10/2011 EASYRA UREA NITROGEN AND CREATININE REAGENTS MEDICA CORP.
K090734 03/19/2009 EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES MEDICA CORP.
K080810 03/21/2008 EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT MEDICA CORP.
K000926 03/22/2000 EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER MEDICA CORP.
K990971 03/23/1999 EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 MEDICA CORP.
K080823 03/24/2008 EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT MEDICA CORP.
K100829 03/24/2010 EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 MEDICA CORP.
K080874 03/31/2008 EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT MEDICA CORP.
K961326 04/08/1996 EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER MEDICA CORP.
K111005 04/11/2011 ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL MEDICA CORP.
K111036 04/14/2011 EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT MEDICA CORPORATION
K101090 04/19/2010 EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS MEDICA CORP.
K101089 04/19/2010 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR MEDICA CORP.
K101088 04/19/2010 EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT MEDICA CORP.
K111363 05/16/2011 PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL MEDICA CORP.
K211559 05/20/2021 EasyStat 300 Medica Corporation
K091991 07/02/2009 EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 MEDICA CORP.
K002407 08/07/2000 EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER MEDICA CORP.
K092506 08/17/2009 EASYRA GLU-H REAGENT, MODEL 10200 MEDICA CORP.
K152327 08/18/2015 EasyLyte Na/K/Cl/Ca Analyzer Medica Corporation
K092737 09/08/2009 EASYRA MG REAGENT, MODEL 10220 MEDICA CORP.
K963694 09/16/1996 EASYLYTE CALCIUM/CHLORIDE ANALYZER MEDICA CORP.
K963763 09/19/1996 EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER MEDICA CORP.
K112788 09/26/2011 EASTLYTE NA/K/CA/PH MEDICA CORP.
K963992 10/04/1996 CAPILLARY ADAPTOR ACCESSORY MEDICA CORP.
K063376 11/08/2006 EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER MEDICA CORP.
K123586 11/21/2012 EASYRA CREATININE REAGENT MEDICA CORPORATION
K955374 11/24/1995 EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER MEDICA CORP.
K955375 11/24/1995 EASYSTAT SODIUM/POTASSIUM ANALYZER MEDICA CORP.
K974526 12/02/1997 EASYBLOOD GAS ANALYZER MEDICA CORP.
K123802 12/10/2012 EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT MEDICA CORP.
K073497 12/13/2007 HDL CHOLESTEROL REAGENT, MODEL 10211 MEDICA CORP.


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