FDA 510(k) Applications Submitted by REBECCA S AYASH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970387 |
02/03/1997 |
HUMAN CHORIONIC GONADOTROPIN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K970393 |
02/03/1997 |
THYROID STIMULATING HORMONE METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K970396 |
02/03/1997 |
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K020979 |
03/26/2002 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 |
DADE BEHRING, INC. |
| K000973 |
03/27/2000 |
BEHRING COAGULATION SYSTEM (BCS) |
DADE BEHRING, INC. |
| K001064 |
04/03/2000 |
BEHRING COAGULATION TIMER ANALYZER (BCT) |
DADE BEHRING, INC. |
| K001067 |
04/03/2000 |
DADE BEHRING COAGULATION ANALYZER (BCT) |
DADE BEHRING, INC. |
| K991176 |
04/07/1999 |
OPUS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K991177 |
04/07/1999 |
OPUS TROPONIN I (CTN) TEST MODULES |
DADE BEHRING, INC. |
| K991385 |
04/21/1999 |
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY |
DADE BEHRING, INC. |
| K991704 |
05/19/1999 |
N/T PROTEIN CONTROL LC |
DADE BEHRING, INC. |
| K991705 |
05/19/1999 |
N PROTEIN STANDARD UY |
DADE BEHRING, INC. |
| K991787 |
05/25/1999 |
N LATEX IGE MONO REAGENT |
DADE BEHRING, INC. |
| K001647 |
05/30/2000 |
BN PROSPEC SYSTEM |
DADE BEHRING, INC. |
| K011665 |
05/30/2001 |
BCT SYSTEM |
DADE BEHRING, INC. |
| K982292 |
06/30/1998 |
PREALBUMIN CALIBRATOR |
DADE BEHRING, INC. |
| K012470 |
08/02/2001 |
MODIFICATION TO N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
| K012468 |
08/02/2001 |
MODIFICATION TO N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
| K982880 |
08/14/1998 |
DIMENSION(R) VALPROIC (VALP) ACID METHOD |
DADE BEHRING, INC. |
| K982871 |
08/14/1998 |
DRUG CALIBRATOR II |
DADE BEHRING, INC. |
| K002541 |
08/16/2000 |
PROTEIN C REAGENT |
DADE BEHRING, INC. |
| K973099 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN CONTROL |
DADE CHEMISTRY SYSTEMS, INC. |
| K973100 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K973101 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K992957 |
09/02/1999 |
ADVANCED D-DIMER |
DADE BEHRING, INC. |
| K992959 |
09/02/1999 |
BEHRING COAGULATION SYSTEM (BCS) |
DADE BEHRING, INC. |
| K002804 |
09/08/2000 |
N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
| K002852 |
09/13/2000 |
N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
| K013114 |
09/18/2001 |
BCS SYSTEM |
DADE BEHRING, INC. |
| K013126 |
09/19/2001 |
N LP(A) STANDARD SY |
DADE BEHRING, INC. |
| K013128 |
09/19/2001 |
N LATEX LP(A) |
DADE BEHRING, INC. |
| K013130 |
09/19/2001 |
N LP(A) CONTROL SY |
DADE BEHRING, INC. |
| K973650 |
09/25/1997 |
TROPONIN (TROP) METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K973668 |
09/25/1997 |
CARDIAC TROPONIN-I (TROP) CALIBRATOR |
DADE INTL., INC. |
| K993273 |
09/30/1999 |
N LATEX FERRITIN |
DADE BEHRING, INC. |
| K983693 |
10/21/1998 |
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K983722 |
10/21/1998 |
STRATUS CS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K983849 |
10/30/1998 |
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K983850 |
10/30/1998 |
DIMENSION AHDL CALIBRATOR |
DADE BEHRING, INC. |
| K003503 |
11/13/2000 |
N LATEX CYSTATIN C |
DADE BEHRING, INC. |
| K003501 |
11/13/2000 |
N PROTEIN STANDARD UY CALIBRATOR |
DADE BEHRING, INC. |
| K984067 |
11/16/1998 |
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK |
DADE BEHRING, INC. |
| K984093 |
11/16/1998 |
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK |
DADE BEHRING, INC. |
| K984065 |
11/16/1998 |
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
| K984191 |
11/23/1998 |
MYOGLOBIN FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K984193 |
11/23/1998 |
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR |
DADE BEHRING, INC. |
| K003870 |
12/15/2000 |
THROMBOREL S |
DADE BEHRING, INC. |
| K994341 |
12/23/1999 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
|
|
