Medica Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTMarch 1, 2013
K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALMay 14, 2012
K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALDecember 6, 2011
K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALNovember 15, 2011
K112788EASTLYTE NA/K/CA/PHOctober 20, 2011
K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORJuly 13, 2011
K101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTSMay 20, 2011
K110675EASYRA UREA NITROGEN AND CREATININE REAGENTSApril 21, 2011
K101088EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTApril 4, 2011
K100829EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEJanuary 14, 2011
K092116EASYCELL CELL LOCATORMay 12, 2010
K100187EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENTMay 5, 2010
K100673EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020April 6, 2010
K092737EASYRA MG REAGENT, MODEL 10220November 17, 2009
K092506EASYRA GLU-H REAGENT, MODEL 10200September 16, 2009
K091991EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200September 4, 2009
K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESJuly 17, 2009
K080404EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIMarch 13, 2009
K080874EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRFebruary 20, 2009
K080810EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGEDecember 10, 2008