FDA 510(k) Applications Submitted by CAROLYN GEORGE

FDA 510(k) Number Submission Date Device Name Applicant
K140191 01/27/2014 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K131381 05/14/2013 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K131935 06/27/2013 ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER NIPRO MEDICAL CORPORATION
K122343 08/03/2012 PUREFLUX-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K122347 08/03/2012 ELISIO-H AND ELISIO-M HEMODIALYZERS NIPRO MEDICAL CORPORATION
K970330 01/28/1997 DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE DADE INTL., INC.
K981097 03/26/1998 STRATUS CS CKMB CALPAK DADE BEHRING, INC.
K981098 03/26/1998 STRATUS CS CARDIAC TROPONIN I TESTPAK DADE BEHRING, INC.
K981099 03/26/1998 STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK DADE BEHRING, INC.
K981100 03/26/1998 STRATUS CS TROP CALPAK DADE BEHRING, INC.
K981101 03/26/1998 STRATUS CS MYO CALPAK DADE BEHRING, INC.
K981102 03/26/1998 STRATUS CS MYOGLOBIN (MYO) TESTPAK DADE BEHRING, INC.
K991157 04/07/1999 N LATEX STFR REAGENT DADE BEHRING, INC.
K991181 04/07/1999 MODIFICATION OF N PROTEIN STANDARD SL DADE BEHRING, INC.
K991182 04/07/1999 MODIFICATION OF N/T PROTEIN CONTROL SL DADE BEHRING, INC.
K091361 05/08/2009 IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS
K962817 07/19/1996 DRUG CALIBRATOR II DADE INTL., INC.
K962818 07/19/1996 TOBRAMYCIN FLEX REAGENT CARTRIDGE DADE INTL., INC.
K962819 07/19/1996 GENTAMICIN FLEX REAGENT CARTRIDGE DADE INTL., INC.
K962820 07/19/1996 CARBAMAZEPINE FLEX REAGENT CARTRIDGE DADE INTL., INC.
K972782 07/25/1997 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY DADE INTL., INC.
K963244 08/19/1996 ACETAMINOPHEN FLEX REAGENT CARTRIDGE DADE INTL., INC.
K963267 08/20/1996 VANCOMYCIN FLEX REAGENT CARTRIDGE DADE INTL., INC.
K984501 12/18/1998 DADE BEHRING BFTII DADE BEHRING, INC.


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