FDA 510(k) Applications Submitted by DONNA A WOLF
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K042687 |
09/29/2004 |
ENZYGNOST F+2 (MONOCLONAL) TEST KIT |
DADE BEHRING, INC. |
| K020692 |
03/04/2002 |
EMIT 2000 VANCOMYCIN ASSAY |
DADE BEHRING, INC. |
| K020845 |
03/15/2002 |
EMIT 2000 VANCOMYCIN CALIBRATORS |
DADE BEHRING, INC. |
| K050665 |
03/15/2005 |
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) |
DADE BEHRING, INC. |
| K010871 |
03/23/2001 |
TGL FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K001256 |
04/19/2000 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
| K021381 |
05/01/2002 |
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 |
DADE BEHRING, INC. |
| K041870 |
07/09/2004 |
N APOLIPOPROTEIN STANDARD SERUM |
DADE BEHRING, INC. |
| K022290 |
07/15/2002 |
PROTEIN S AC |
DADE BEHRING, INC. |
| K042209 |
08/16/2004 |
CONTROL PLASMA N AND CONTROL PLASMA P |
DADE BEHRING, INC. |
| K023141 |
09/20/2002 |
MODIFICATION TO STANDARD HUMAN PLASMA |
DADE BEHRING, INC. |
| K023309 |
10/03/2002 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
| K023312 |
10/03/2002 |
CONTROL PLASMA P |
DADE BEHRING, INC. |
| K993310 |
10/04/1999 |
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
DADE BEHRING, INC. |
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