Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
Chemistry
11d
Cleared
Dec 13, 2001
IMMUNO-TROL LOW CELLS
Hematology
23d
Cleared
Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
Toxicology
89d
Cleared
Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
Chemistry
48d
Cleared
Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
Chemistry
18d
Cleared
Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY...
Immunology
53d
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Hematology
119d
Cleared
Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Hematology
68d
Cleared
Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Microbiology
238d
Cleared
Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Chemistry
25d
Cleared
Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
Chemistry
112d
Cleared
May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
Chemistry
90d
Cleared
May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
Chemistry
26d
Cleared
May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
Immunology
63d
Cleared
Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
Hematology
30d
Cleared
Apr 11, 2001
VIGIL DNASE B CONTROL
Immunology
34d
Cleared
Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
Immunology
70d
Cleared
Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
Chemistry
28d
Cleared
Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
Immunology
27d
Cleared
Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
Hematology
30d
Cleared
Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
Hematology
30d
Cleared
Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
Chemistry
71d
Cleared
Nov 27, 2000
SYNCHRON CONTROL
Toxicology
14d
Cleared
Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
Chemistry
48d
Cleared
Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
Immunology
31d
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