FDA 510(k) Applications Submitted by LORRAINE H PIESTRAK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990824 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
| K990825 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K031135 |
04/09/2003 |
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) |
DADE BEHRING, INC. |
| K023065 |
09/16/2002 |
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K060090 |
01/12/2006 |
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K070552 |
02/27/2007 |
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) |
DADE BEHRING, INC. |
| K011112 |
04/11/2001 |
CYCLOSPORINE CALIBRATOR |
DADE BEHRING, INC. |
| K061020 |
04/13/2006 |
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE |
DADE BEHRING, INC. |
| K051087 |
04/28/2005 |
DIMENSION VISTA INTEGRATED SYSTEM |
DADE BEHRING, INC. |
| K071224 |
05/02/2007 |
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR |
DADE BEHRING, INC. |
| K061238 |
05/03/2006 |
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K061251 |
05/04/2006 |
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR |
DADE BEHRING, INC. |
| K061655 |
06/13/2006 |
DIMENSION VISTA FLEX REAGENT CARTRIDGES |
DADE BEHRING, INC. |
| K061792 |
06/26/2006 |
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI |
DADE BEHRING, INC. |
| K062024 |
07/18/2006 |
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K062128 |
07/26/2006 |
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS |
DADE BEHRING, INC. |
| K062236 |
08/02/2006 |
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K062316 |
08/09/2006 |
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K032697 |
09/02/2003 |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
DADE BEHRING, INC. |
| K983344 |
09/23/1998 |
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL |
DADE BEHRING, INC. |
| K112999 |
10/07/2011 |
DIMENSION CLINICAL CHEMISTRY SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K053531 |
12/19/2005 |
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR |
DADE BEHRING, INC. |
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