Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
Chemistry
25d
Cleared
May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
Chemistry
59d
Cleared
Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
Chemistry
16d
Cleared
Oct 06, 2006
ACCESS EPO ASSAY
Hematology
417d
Cleared
Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920...
Immunology
38d
Cleared
Oct 04, 2006
COULTER LH 780 HEMATOLOGY ANALYZER
Hematology
118d
Cleared
Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
Chemistry
140d
Cleared
Jul 21, 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Hematology
44d
Cleared
Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND...
Immunology
49d
Cleared
Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
Chemistry
25d
Cleared
May 17, 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
Hematology
30d
Cleared
Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
Chemistry
23d
Cleared
Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
Chemistry
120d
Cleared
Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
Chemistry
30d
Cleared
Mar 28, 2006
COULTER 5C CELL CONTROL
Hematology
34d
Cleared
Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
Chemistry
26d
Cleared
Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
Immunology
26d
Cleared
Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
Chemistry
44d
Cleared
Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
Hematology
35d
Cleared
Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
Immunology
17d
Cleared
Aug 01, 2005
ITAG MHC TETRAMER CMV ASSAY
Hematology
91d
Cleared
Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
Chemistry
25d
Cleared
May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION...
Immunology
108d
Cleared
Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
Chemistry
91d
Cleared
Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
Hematology
30d
Looking for a specific device from Beckman Coulter, Inc.? Search by device name or K-number.
Search all Beckman Coulter, Inc. devices