Atlas FDA

KTN

59 FDA 510(k) clearances · Product code

41 daysmedian time to decision
179 days90th percentile
59clearances measured

FDA profile

Official device name
System, Test, Infectious Mononucleosis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5640
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1 · 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (K181436)SEKISUI Diagnostics, LLC2018-06-22
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (K042272)ACON Laboratories, Inc.2005-02-28
BIORAPID MONONUCLEOSIS (K030215)Instrumentation Laboratory CO2003-02-24
COLOR-MONOGEN (K012901)Instrumentation Laboratory CO2001-09-27
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (K982634)Oxoid , Ltd.1999-01-28
CLEARVIEW IM (K981946)Unipath , Ltd.1998-12-10
MONOCOL/LEX-IM TEST (K972457)Immunostics Inc.,1997-12-01
OSOM MONO TEST 143 (K972231)Wyntek Diagnostics, Inc.1997-08-26
GENZYME DIAGNOSTICS CONTRAST MONO (K963425)Genzyme Diagnostics1997-02-25
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (K961024)Princeton BioMeditech Corp.1997-02-04
QUALITROL MONO CONTROL SERUM SET (K961550)Consolidated Technologies, Inc.1996-09-24
IMMUNOCARD MONO (K930778)Meridian Diagnostics, Inc.1993-12-27
EYE SPOT IM TEST (K932688)J.S. Medical Assoc.1993-09-08
ACCUTEX IM LATEX TEST (K932551)J.S. Medical Assoc.1993-08-09
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (K925183)Princeton Biomedix1993-02-23
ACCUTEX IM RBC TEST (K924037)J.S. Medical Assoc.1992-11-02
PULSE IM RED CELL TEST (K923767)Pulse Scientific, Inc.1992-10-16
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL (K922726)Simplicity Diagnostics, Inc.1992-10-05
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (K922296)Ampcor, Inc.1992-07-14
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (K922297)Ampcor, Inc.1992-07-14
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY (K920221)Akers Research Corp.1992-03-13
CARDS O.S. MONO (K902510)Pacific Biotech, Inc.1990-07-16
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX (K902541)Trinity Laboratories, Inc.1990-06-28
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET (K900625)Armkel, LLC1990-02-26
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS (K896926)Quidel Corp.1990-01-26
LEECO PREVIEW(R) EBV (EIA) (K895765)Leeco Diagnostics, Inc.1989-10-31
DETECTADOT SYSTEM 2000 HETEROPHILE TEST (K895891)Gull Laboratories, Inc.1989-10-31
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST (K894975)General Biometrics, Inc.1989-09-13
MONODEX (K894793)Cenogenics Corp.1989-08-21
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST (K893737)Quidel Corp.1989-06-16
MONO-CUBE(TM) (K890991)Difco Laboratories, Inc.1989-03-16
V-TREND TARGET IM TEST (K890041)Texas Immunology, Inc.1989-01-23
MODIFICATION OF MONO-PLUS(TM) (K883709)Armkel, LLC1988-12-20
CARDS(TM) MONO (K884007)Pacific Biotech, Inc.1988-11-18
OXOID INFECTIOUS MONONUCLEOSIS KIT (K883540)Unipath , Ltd.1988-10-19
MONO-PLUS(TM) (K883004)Wampole Laboratories1988-08-04
MONO-PHILE (K881247)Bio Diagnostic Systems, Inc.1988-04-07
V-TREND IM DRY-SPOT TEST (K880399)Texas Immunology, Inc.1988-02-17
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST (K880148)Ampcor, Inc.1988-02-10
I.M.N. LATEX (K874678)Biokit USA, Inc.1987-12-14
DIFFERENTIAL I.M. SCREENING TEST (K873297)Sclavo, Inc.1987-12-14
VENTRESCREEN (TM) MONO (K872032)Ventrex Laboratories, Inc.1987-06-29
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO (K864207)Gamma Biologicals, Inc.1986-12-03
MONO-LATEX (TM) SLIDE TEST (K862008)Armkel, LLC1986-07-03
MONOSTAR SYSTEM: IM LATEX TEST (K861452)U.S. Health Resources Corp.1986-05-13
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS (K861016)Gamma Biologicals, Inc.1986-04-18
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 (K853144)Preco, Inc.1985-10-16
IMMUNO-IM (K853105)Immunostics Co., Inc.1985-09-03
MONOSTICON UNI-DOT (K853388)Organon, Inc.1985-08-22
SERIES I/S INFECTIONS (K844289)American Dade1984-11-19
MONO-TEC (K841863)Medilab Corp.1984-06-13
LEAP MONO TEST KIT (K840822)Cooper Biomedical, Inc.1984-04-05
IM-CHECK (K834345)Diagnostic Technology, Inc.1984-02-10
MONO SCREENING TEST (K830531)Tago, Inc.1983-03-17
SERO/TEX MONO TEST (K821386)Texas Immunology, Inc.1982-07-02
CORDIA IM (K812540)Cordis Corp.1981-09-24
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS (K791455)Volu Sol Medical Industries1979-12-31
MONOSTICON TEST (K771397)Organon, Inc.1977-08-22
TEST, MONO., CARD (MACRO-VUE) (K760040)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-08-03

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Every clearance here is in the API, with alerts when new ones post.