|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
easystat 300
|
Medica corporation
|
K220396 |
09/26/2023
|
advia centaur® nt-probnpii (pbnpii)
|
Siemens Healthcare Diagnostics, Inc.
|
K220265 |
09/24/2023
|
access cea
|
Beckman Coulter, Inc
|
K223921 |
09/22/2023
|
alfis vitamin d, alfis-3 analyzer
|
Immunostics Inc.
|
K221817 |
09/22/2023
|
ilet® dosing decision software
|
Beta Bionics, Inc.
|
K232224 |
09/22/2023
|
architect hsv-1 igg, architect hsv-1 igg calibrator, architect hsv-1 igg controls
|
Biokit, S.A.
|
K213987 |
09/20/2023
|
cholestech ldx ™ system
|
Alere San Diego, Inc.
|
K223179 |
09/20/2023
|
ai100 with shonit
|
SigTuple Technologies Pvt. Ltd.
|
K221309 |
09/19/2023
|
access myoglobin
|
Beckman Coulter, Inc
|
K231832 |
09/18/2023
|
b·r·a·h·m·s cga ii kryptor, b·r·a·h·m·s cga ii kryptor cal, b·r·a·h·m·s cga ii kryptor qc
|
B.R.A.H.M.S GmbH part of Thermo Fisher
|
K222251 |
09/18/2023
|
|