Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
34 devices
Cleared
Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam...
Microbiology
128d
Cleared
Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
Microbiology
172d
Cleared
Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
Microbiology
27d
Cleared
May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
Microbiology
53d
Cleared
Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
Microbiology
24d
Cleared
Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
Microbiology
29d
Cleared
Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
Microbiology
19d
Cleared
Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
Microbiology
238d
Cleared
Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS...
Microbiology
21d