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FDA 510(k) Applications Submitted by GAIL L EFEBVRE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K000494
02/15/2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
BECKMAN COULTER, INC.
K020521
02/19/2002
MODIFICATION TO VIGIL LIPID CONTROL
BECKMAN COULTER, INC.
K993022
09/09/1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
BECKMAN COULTER, INC.
K993473
10/14/1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
BECKMAN COULTER, INC.
K003488
11/13/2000
SYNCHRON CONTROL
BECKMAN COULTER, INC.
K000331
12/22/1999
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
BECKMAN COULTER, INC.
K994325
12/22/1999
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
BECKMAN COULTER, INC.
K993023
09/09/1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
BECKMAN COULTER, INC.
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