Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
Immunology
15d
Cleared
May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Immunology
11d
Cleared
May 02, 2003
ACCESS OV MONITOR ASSAY
Immunology
8d
Cleared
Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
Toxicology
29d
Cleared
Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
Hematology
55d
Cleared
Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
Hematology
79d
Cleared
Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...
Hematology
25d
Cleared
Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
Immunology
66d
Cleared
Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Chemistry
77d
Cleared
Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
Chemistry
15d
Cleared
Dec 20, 2002
ACCESS TOTAL BHCG
Chemistry
64d
Cleared
Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
Immunology
44d
Cleared
Dec 09, 2002
ACCESS TOTAL T4 ASSAY
Chemistry
62d
Cleared
Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
Chemistry
68d
Cleared
Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Toxicology
55d
Cleared
Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
Chemistry
22d
Cleared
Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Chemistry
116d
Cleared
Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Hematology
26d
Cleared
Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
Immunology
66d
Cleared
Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Chemistry
71d
Cleared
Jun 11, 2002
COULTER CELLPREP
Hematology
62d
Cleared
Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
Chemistry
10d
Cleared
Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
Toxicology
57d
Cleared
Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
Chemistry
46d
Cleared
Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
Chemistry
43d
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