KTN · Class II · 21 CFR 866.5640

FDA Product Code KTN: System, Test, Infectious Mononucleosis

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

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 Dec 01, 1997
MONOCOL/LEX-IM TEST
K972457
Immunostics Inc.,
Immunology · 153d
Cleared Aug 26, 1997
OSOM MONO TEST 143
K972231
Wyntek Diagnostics, Inc.
Immunology · 71d
Cleared Feb 25, 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425
Genzyme Diagnostics
Immunology · 179d
Cleared Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024
Princeton BioMeditech Corp.
Immunology · 327d
Cleared Sep 24, 1996
QUALITROL MONO CONTROL SERUM SET
K961550
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778
Meridian Diagnostics, Inc.
Immunology · 314d
Cleared Sep 08, 1993
EYE SPOT IM TEST
K932688
J.S. Medical Assoc.
Immunology · 97d
Cleared Aug 09, 1993
ACCUTEX IM LATEX TEST
K932551
J.S. Medical Assoc.
Immunology · 75d
Cleared Feb 23, 1993
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
K925183
Princeton Biomedix
Immunology · 132d
Cleared Nov 02, 1992
ACCUTEX IM RBC TEST
K924037
J.S. Medical Assoc.
Immunology · 83d
Cleared Oct 16, 1992
PULSE IM RED CELL TEST
K923767
Pulse Scientific, Inc.
Immunology · 80d
Cleared Oct 05, 1992
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
K922726
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Jul 14, 1992
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
K922296
Ampcor, Inc.
Immunology · 60d
Cleared Jul 14, 1992
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
K922297
Ampcor, Inc.
Immunology · 60d
Cleared Mar 13, 1992
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
K920221
Akers Research Corp.
Immunology · 57d
Cleared Jul 16, 1990
CARDS O.S. MONO
K902510
Pacific Biotech, Inc.
Microbiology · 41d
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

About Product Code KTN - Regulatory Context