Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Hematology
164d
Cleared
May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
Microbiology
266d
Cleared
Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64...
Microbiology
90d
Cleared
Aug 30, 2020
LabPro Data Management System
Microbiology
94d
Cleared
Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32...
Microbiology
31d
Cleared
Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004...
Microbiology
89d
Cleared
Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx)...
Microbiology
90d
Cleared
Nov 26, 2019
Access PCT, Access PCT Calibrators
Microbiology
96d
Cleared
Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
Microbiology
77d
Cleared
Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)...
Microbiology
85d
Cleared
Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam...
Microbiology
91d
Cleared
Jun 14, 2018
Access hsTnl
Chemistry
272d
Cleared
Jun 12, 2018
Access hs Tnl
Chemistry
270d
Cleared
Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam...
Microbiology
135d
Cleared
Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 –...
Microbiology
73d
Cleared
Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam...
Microbiology
128d
Cleared
Nov 13, 2017
Access AMH
Chemistry
264d
Cleared
Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
Microbiology
172d
Cleared
Jan 09, 2017
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
Immunology
157d
Cleared
Dec 16, 2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
Chemistry
164d
Cleared
Nov 29, 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
Hematology
92d
Cleared
Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access...
Chemistry
241d
Cleared
Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
Microbiology
27d
Cleared
Apr 10, 2015
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS...
Immunology
268d
Cleared
Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON...
Chemistry
133d
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