KTN · Class II · 21 CFR 866.5640

FDA Product Code KTN: System, Test, Infectious Mononucleosis

Leading manufacturers include Armkel, LLC, Organon, Inc. and Unipath , Ltd..

59
Total
59
Cleared
70d
Avg days
1976
Since

FDA 510(k) Cleared System, Test, Infectious Mononucleosis Devices (Product Code KTN)

59 devices
1–24 of 59
Cleared Jun 22, 2018
OSOM Mono Test
K181436
SEKISUI Diagnostics, LLC
Microbiology · 21d
Cleared Feb 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272
ACON Laboratories, Inc.
Immunology · 189d
Cleared Feb 24, 2003
BIORAPID MONONUCLEOSIS
K030215
Instrumentation Laboratory CO
Immunology · 34d
Cleared Sep 27, 2001
COLOR-MONOGEN
K012901
Instrumentation Laboratory CO
Immunology · 29d
Cleared Jan 28, 1999
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634
Oxoid , Ltd.
Immunology · 184d
Cleared Dec 10, 1998
CLEARVIEW IM
K981946
Unipath , Ltd.
Immunology · 190d
Cleared Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024
Princeton BioMeditech Corp.
Immunology · 327d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778
Meridian Diagnostics, Inc.
Immunology · 314d
Cleared Jun 28, 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541
Trinity Laboratories, Inc.
Immunology · 22d
Cleared Feb 26, 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625
Armkel, LLC
Immunology · 18d
Cleared Jan 26, 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926
Quidel Corp.
Immunology · 46d
Cleared Oct 31, 1989
LEECO PREVIEW(R) EBV (EIA)
K895765
Leeco Diagnostics, Inc.
Immunology · 35d
Cleared Oct 31, 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891
Gull Laboratories, Inc.
Immunology · 26d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737
Quidel Corp.
Immunology · 30d
Cleared Mar 16, 1989
MONO-CUBE(TM)
K890991
Difco Laboratories, Inc.
Immunology · 17d
Cleared Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
K883709
Armkel, LLC
Immunology · 112d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540
Unipath , Ltd.
Immunology · 62d
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 Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008
Armkel, LLC
Immunology · 37d
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 Sep 24, 1981
CORDIA IM
K812540
Cordis Corp.
Immunology · 20d
Cleared Dec 31, 1979
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455
Volu Sol Medical Industries
Immunology · 147d

About Product Code KTN - Regulatory Context