Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
269
results for "Beckman Coulter, Inc."
Cleared
Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...
Beckman Coulter, Inc.
Immunology
37d
Cleared
Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
Beckman Coulter, Inc.
Hematology
24d
Cleared
Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
Beckman Coulter, Inc.
Toxicology
28d
Cleared
Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
Beckman Coulter, Inc.
Microbiology
29d
Cleared
Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
Beckman Coulter, Inc.
Microbiology
19d
Cleared
May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
Beckman Coulter, Inc.
Hematology
68d
Cleared
May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Immunology
15d
Cleared
May 02, 2003
ACCESS OV MONITOR ASSAY
Beckman Coulter, Inc.
Immunology
8d
Cleared
May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Beckman Coulter, Inc.
Immunology
11d
Cleared
Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
Beckman Coulter, Inc.
Toxicology
29d
Cleared
Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
Beckman Coulter, Inc.
Hematology
55d
Cleared
Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
Beckman Coulter, Inc.
Hematology
79d
Cleared
Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...
Beckman Coulter, Inc.
Hematology
25d
Cleared
Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
Beckman Coulter, Inc.
Immunology
66d
Cleared
Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Beckman Coulter, Inc.
Chemistry
77d
Cleared
Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
Beckman Coulter, Inc.
Chemistry
15d
Cleared
Dec 20, 2002
ACCESS TOTAL BHCG
Beckman Coulter, Inc.
Chemistry
64d
Cleared
Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
Beckman Coulter, Inc.
Immunology
44d
Cleared
Dec 09, 2002
ACCESS TOTAL T4 ASSAY
Beckman Coulter, Inc.
Chemistry
62d
Cleared
Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
Beckman Coulter, Inc.
Chemistry
68d
Cleared
Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Beckman Coulter, Inc.
Toxicology
55d
Cleared
Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
Beckman Coulter, Inc.
Chemistry
22d
Cleared
Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Beckman Coulter, Inc.
Chemistry
116d
Cleared
Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Beckman Coulter, Inc.
Hematology
26d