Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
Hematology
260d
Cleared
May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
Chemistry
130d
Cleared
Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
Immunology
119d
Cleared
Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
Chemistry
28d
Cleared
Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
Chemistry
116d
Cleared
Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING...
Chemistry
241d
Cleared
Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
Chemistry
59d
Cleared
Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
Chemistry
83d
Cleared
May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE,...
Chemistry
84d
Cleared
Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
Chemistry
243d
Cleared
Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN...
Chemistry
364d
Cleared
Feb 03, 2009
COULTER BODY FLUID CONTROL
Hematology
187d
Cleared
Jan 21, 2009
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
Hematology
208d
Cleared
Jan 16, 2009
COULTER LIN-X LINEARITY CONTROL
Hematology
219d
Cleared
Dec 19, 2008
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Hematology
165d
Cleared
Aug 14, 2008
FLOWCARE TLG REAGENT
Hematology
73d
Cleared
Aug 11, 2008
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493,...
Immunology
158d
Cleared
Jun 25, 2008
HEMOCCULT ICT
Hematology
93d
Cleared
May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
Microbiology
53d
Cleared
Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
Chemistry
56d
Cleared
Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND...
Immunology
39d
Cleared
Oct 04, 2007
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
Hematology
107d
Cleared
Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN...
Chemistry
73d
Cleared
Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Chemistry
25d
Cleared
Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Chemistry
25d
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