Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
116 devices
Cleared
Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON...
Chemistry
133d
Cleared
Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access...
Chemistry
119d
Cleared
Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access...
Chemistry
116d
Cleared
Sep 16, 2014
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access...
Chemistry
201d
Cleared
Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
Chemistry
104d
Cleared
Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
Chemistry
356d
Cleared
Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
Chemistry
271d
Cleared
Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS...
Chemistry
464d
Cleared
Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE...
Chemistry
417d
Cleared
Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
Chemistry
263d
Cleared
Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
Chemistry
113d
Cleared
Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
Chemistry
123d
Cleared
Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
Chemistry
39d
Cleared
May 25, 2011
SYNCHRON MULTI CALIBRATOR
Chemistry
117d
Cleared
May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
Chemistry
86d
Cleared
Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800...
Chemistry
118d
Cleared
May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
Chemistry
130d
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
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