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
25–48 of 59
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 Sep 13, 1989
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975
General Biometrics, Inc.
Immunology · 37d
Cleared Aug 21, 1989
MONODEX
K894793
Cenogenics Corp.
Immunology · 24d
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 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 Aug 04, 1988
MONO-PLUS(TM)
K883004
Wampole Laboratories
Immunology · 17d
Cleared Apr 07, 1988
MONO-PHILE
K881247
Bio Diagnostic Systems, Inc.
Immunology · 15d
Cleared Feb 17, 1988
V-TREND IM DRY-SPOT TEST
K880399
Texas Immunology, Inc.
Immunology · 19d
Cleared Feb 10, 1988
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
K880148
Ampcor, Inc.
Immunology · 28d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297
Sclavo, Inc.
Immunology · 118d
Cleared Dec 14, 1987
I.M.N. LATEX
K874678
Biokit USA, Inc.
Immunology · 31d
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 May 13, 1986
MONOSTAR SYSTEM: IM LATEX TEST
K861452
U.S. Health Resources Corp.
Immunology · 25d
Cleared Apr 18, 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016
Gamma Biologicals, Inc.
Immunology · 31d
Cleared Oct 16, 1985
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144
Preco, Inc.
Immunology · 79d
Cleared Sep 03, 1985
IMMUNO-IM
K853105
Immunostics Co., Inc.
Immunology · 42d