KTN · Class II · 21 CFR 866.5640

FDA Product Code KTN: System, Test, Infectious Mononucleosis

Leading manufacturers include Armkel, LLC, J.S. Medical Assoc. and Ampcor, Inc..

59
Total
59
Cleared
70d
Avg days
1976
Since
59 devices
49–59 of 59
Cleared Aug 22, 1985
MONOSTICON UNI-DOT
K853388
Organon, Inc.
Immunology · 9d
Cleared Nov 19, 1984
SERIES I/S INFECTIONS
K844289
American Dade
Immunology · 14d
Cleared Jun 13, 1984
MONO-TEC
K841863
Medilab Corp.
Immunology · 40d
Cleared Apr 05, 1984
LEAP MONO TEST KIT
K840822
Cooper Biomedical, Inc.
Immunology · 41d
Cleared Feb 10, 1984
IM-CHECK
K834345
Diagnostic Technology, Inc.
Immunology · 60d
Cleared Mar 17, 1983
MONO SCREENING TEST
K830531
Tago, Inc.
Immunology · 27d
Cleared Jul 02, 1982
SERO/TEX MONO TEST
K821386
Texas Immunology, Inc.
Immunology · 53d
Cleared Sep 24, 1981
CORDIA IM
K812540
Cordis Corp.
Immunology · 20d
Cleared Dec 31, 1979
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455
Volu Sol Medical Industries
Immunology · 147d
Cleared Aug 22, 1977
MONOSTICON TEST
K771397
Organon, Inc.
Immunology · 24d
Cleared Aug 03, 1976
TEST, MONO., CARD (MACRO-VUE)
K760040
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 49d