KTN · Class II · 21 CFR 866.5640

FDA Product Code KTN: System, Test, Infectious Mononucleosis

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

59
Total
59
Cleared
70d
Avg days
1976
Since
59 devices
25–48 of 59
Cleared Jan 23, 1989
V-TREND TARGET IM TEST
K890041
Texas Immunology, Inc.
Immunology · 18d
Cleared Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
K883709
Armkel, LLC
Immunology · 112d
Cleared Nov 18, 1988
CARDS(TM) MONO
K884007
Pacific Biotech, Inc.
Immunology · 58d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540
Unipath , Ltd.
Immunology · 62d
Cleared Feb 17, 1988
V-TREND IM DRY-SPOT TEST
K880399
Texas Immunology, Inc.
Immunology · 19d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297
Sclavo, Inc.
Immunology · 118d
Cleared Jun 29, 1987
VENTRESCREEN (TM) MONO
K872032
Ventrex Laboratories, Inc.
Immunology · 33d
Cleared Dec 03, 1986
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207
Gamma Biologicals, Inc.
Immunology · 37d
Cleared Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008
Armkel, LLC
Immunology · 37d
Cleared Apr 18, 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016
Gamma Biologicals, Inc.
Immunology · 31d
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 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 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