FDA Product Code KTN: System, Test, Infectious Mononucleosis
Leading manufacturers include Instrumentation Laboratory CO, SEKISUI Diagnostics, LLC and Bd Becton Dickinson Vacutainer Systems Preanalytic.
59
Total
59
Cleared
70d
Avg days
1976
Since
FDA 510(k) Cleared System, Test, Infectious Mononucleosis Devices (Product Code KTN)
59 devices
Cleared
Jun 22, 2018
OSOM Mono Test
SEKISUI Diagnostics, LLC
Microbiology
21d
Cleared
Feb 24, 2003
BIORAPID MONONUCLEOSIS
Instrumentation Laboratory CO
Immunology
34d
Cleared
Sep 27, 2001
COLOR-MONOGEN
Instrumentation Laboratory CO
Immunology
29d
Cleared
Sep 24, 1981
CORDIA IM
Cordis Corp.
Immunology
20d
Cleared
Aug 03, 1976
TEST, MONO., CARD (MACRO-VUE)
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology
49d