|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
tandem mobi insulin pump with interoperable technology
|
Tandem Diabetes Care, Inc.
|
K240309 |
03/21/2024
|
access ferritin
|
Beckman Coulter, Inc
|
K234052 |
03/20/2024
|
pathfast®hs-ctni-ii
|
PHC Corporation
|
K231974 |
03/20/2024
|
arx viral transport media collection and transport system
|
ARX Sciences, Inc.
|
K231843 |
03/19/2024
|
bd phoenix™ automated microbiology system - gn ciprofloxacin (0.0156–4 µg/ml)
|
Becton, Dickinson and Company
|
K233986 |
03/15/2024
|
xprecia prime coagulation system
|
Universal Biosensors Pty Ltd
|
K230802 |
03/15/2024
|
deka ace pump system
|
Deka Research and Development
|
K233952 |
03/13/2024
|
deka loop
|
Deka Research and Development
|
K234055 |
03/13/2024
|
immulite® 2000 br-ma
|
Siemens Healthcare Diagnostics Products Ltd
|
K233946 |
03/13/2024
|
nxtag respiratory pathogen panel v2 (nxtag rpp v2)
|
Luminex Molecular Diagnostics, Inc.
|
K231758 |
03/11/2024
|