Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
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
Sep 05, 2014
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER...
Hematology
149d
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
Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
Immunology
355d
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
Sep 18, 2013
NAVIOS FLOW CYTOMETER SYSTEM
Hematology
216d
Cleared
Jul 26, 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
Hematology
437d
Cleared
Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
Immunology
164d
Cleared
Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE...
Chemistry
417d
Cleared
Mar 22, 2013
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Hematology
373d
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 27, 2011
ACCESS THYROGLOBULIN ANITBODY
Immunology
85d
Cleared
Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
Chemistry
123d
Cleared
Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
Immunology
58d
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
Feb 07, 2011
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
Toxicology
82d
Cleared
Dec 21, 2010
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
Hematology
274d
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