Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
116 devices
Cleared
Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Chemistry
25d
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 09, 2002
ACCESS TOTAL T4 ASSAY
Chemistry
62d
Cleared
Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
Chemistry
68d
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
Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Chemistry
71d
Cleared
Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
Chemistry
10d
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
Cleared
Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
Chemistry
11d
Cleared
Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
Chemistry
48d
Cleared
Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
Chemistry
18d
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
Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
Chemistry
28d
Cleared
Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
Chemistry
71d
Cleared
Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
Chemistry
48d
Cleared
Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
Chemistry
27d
Cleared
Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER,...
Chemistry
57d
Cleared
Jun 02, 2000
SYNCHRON CONTROL
Chemistry
23d
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