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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