Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Chemistry
12d
Cleared
Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
Hematology
61d
Cleared
Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
Chemistry
68d
Cleared
Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
Chemistry
80d
Cleared
Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
Hematology
28d
Cleared
Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
Hematology
62d
Cleared
Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Toxicology
7d
Cleared
Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS...
Chemistry
34d
Cleared
Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
Chemistry
23d
Cleared
Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
Chemistry
62d
Cleared
Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
Chemistry
74d
Cleared
Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
Chemistry
57d
Cleared
Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...
Immunology
127d
Cleared
Dec 29, 2003
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...
Immunology
91d
Cleared
Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS,...
Chemistry
32d
Cleared
Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
Hematology
59d
Cleared
Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Chemistry
25d
Cleared
Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
Hematology
64d
Cleared
Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
Microbiology
24d
Cleared
Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...
Immunology
37d
Cleared
Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
Hematology
24d
Cleared
Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
Toxicology
28d
Cleared
Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
Microbiology
29d
Cleared
Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
Microbiology
19d
Cleared
May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
Hematology
68d
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