FDA 510(k) Applications Submitted by LUCINDA STOCKERT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000410 |
02/08/2000 |
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
BECKMAN COULTER, INC. |
| K000606 |
02/23/2000 |
SYNCHRON SYSTEMS AMPHETAMINE REAGENT |
BECKMAN COULTER, INC. |
| K971203 |
04/01/1997 |
SYNCHRON SYSTEMS THYROXINE REAGENT |
BECKMAN INSTRUMENTS, INC. |
| K971333 |
04/10/1997 |
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD |
BECKMAN INSTRUMENTS, INC. |
| K001458 |
05/10/2000 |
SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
| K971958 |
05/28/1997 |
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT |
BECKMAN INSTRUMENTS, INC. |
| K982022 |
06/09/1998 |
VIGIL HEMOGLOBIN (HBALC) CONTROLS |
BECKMAN COULTER, INC. |
| K972819 |
07/29/1997 |
VIGIL TDM CONTROLS |
BECKMAN INSTRUMENTS, INC. |
| K973069 |
08/18/1997 |
SYNCHRON SYSTEMS METHADONE REAGENT |
BECKMAN INSTRUMENTS, INC. |
| K982935 |
08/21/1998 |
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR |
BECKMAN COULTER, INC. |
| K983209 |
09/14/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I |
BECKMAN COULTER, INC. |
| K973696 |
09/26/1997 |
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT |
BECKMAN INSTRUMENTS, INC. |
| K003196 |
10/12/2000 |
SYNCHRON SYSTEMS AMMONIA REAGENT |
BECKMAN COULTER, INC. |
| K983640 |
10/16/1998 |
SYNCHRON SYSTEMS LIPID CALIBRATOR |
BECKMAN COULTER, INC. |
| K983709 |
10/21/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 |
BECKMAN COULTER, INC. |
| K983747 |
10/23/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II |
BECKMAN COULTER, INC. |
| K984014 |
11/11/1998 |
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
| K984152 |
11/19/1998 |
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT |
BECKMAN COULTER, INC. |
| K993954 |
11/22/1999 |
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS |
BECKMAN COULTER, INC. |
| K013990 |
12/03/2001 |
LIFESTITCH SUTURING DEVICE |
EDWARDS LIFESCIENCES, LLC. |
| K984402 |
12/09/1998 |
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT |
BECKMAN COULTER, INC. |
| K994168 |
12/10/1999 |
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
| K994169 |
12/10/1999 |
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
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