Panels › Immunology › Product code KTN · Class 2
System, Test, Infectious Mononucleosis
Regulation 866.5640
0510(k)s in 12 months (59 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in KTN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2018 | K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test SEKISUI Diagnostics, LLC | KTN |
| Feb 28, 2005 | K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON Laboratories, Inc. | KTN |
| Feb 24, 2003 | K030215 | BIORAPID MONONUCLEOSIS Instrumentation Laboratory CO | KTN |
| Sep 27, 2001 | K012901 | COLOR-MONOGEN Instrumentation Laboratory CO | KTN |
| Jan 28, 1999 | K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT Oxoid , Ltd., GB | KTN |
| Dec 10, 1998 | K981946 | CLEARVIEW IM Unipath , Ltd., GB | KTN |
| Dec 1, 1997 | K972457 | MONOCOL/LEX-IM TEST Immunostics Inc., | KTN |
| Aug 26, 1997 | K972231 | OSOM MONO TEST 143 Wyntek Diagnostics, Inc. | KTN |
| Feb 25, 1997 | K963425 | GENZYME DIAGNOSTICS CONTRAST MONO Genzyme Diagnostics | KTN |
| Feb 4, 1997 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB Princeton BioMeditech Corp. | KTN |
| Sep 24, 1996 | K961550 | QUALITROL MONO CONTROL SERUM SET Consolidated Technologies, Inc. | KTN |
| Dec 27, 1993 | K930778 | IMMUNOCARD MONO Meridian Diagnostics, Inc. | KTN |
| Sep 8, 1993 | K932688 | EYE SPOT IM TEST J.S. Medical Assoc. | KTN |
| Aug 9, 1993 | K932551 | ACCUTEX IM LATEX TEST J.S. Medical Assoc. | KTN |
| Feb 23, 1993 | K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST Princeton Biomedix | KTN |
| Nov 2, 1992 | K924037 | ACCUTEX IM RBC TEST J.S. Medical Assoc. | KTN |
| Oct 16, 1992 | K923767 | PULSE IM RED CELL TEST Pulse Scientific, Inc., CA | KTN |
| Oct 5, 1992 | K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL Simplicity Diagnostics, Inc. | KTN |
| Jul 14, 1992 | K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST Ampcor, Inc. | KTN |
| Jul 14, 1992 | K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST Ampcor, Inc. | KTN |
| Mar 13, 1992 | K920221 | HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY Akers Research Corp. | KTN |
| Jul 16, 1990 | K902510 | CARDS O.S. MONO Pacific Biotech, Inc. | KTN |
| Jun 28, 1990 | K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX Trinity Laboratories, Inc. | KTN |
| Feb 26, 1990 | K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET Armkel, LLC | KTN |
| Jan 26, 1990 | K896926 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS Quidel Corp. | KTN |
| Oct 31, 1989 | K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST Gull Laboratories, Inc. | KTN |
| Oct 31, 1989 | K895765 | LEECO PREVIEW(R) EBV (EIA) Leeco Diagnostics, Inc. | KTN |
| Sep 13, 1989 | K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST General Biometrics, Inc. | KTN |
| Aug 21, 1989 | K894793 | MONODEX Cenogenics Corp. | KTN |
| Jun 16, 1989 | K893737 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST Quidel Corp. | KTN |
| Mar 16, 1989 | K890991 | MONO-CUBE(TM) Difco Laboratories, Inc. | KTN |
| Jan 23, 1989 | K890041 | V-TREND TARGET IM TEST Texas Immunology, Inc. | KTN |
| Dec 20, 1988 | K883709 | MODIFICATION OF MONO-PLUS(TM) Armkel, LLC | KTN |
| Nov 18, 1988 | K884007 | CARDS(TM) MONO Pacific Biotech, Inc. | KTN |
| Oct 19, 1988 | K883540 | OXOID INFECTIOUS MONONUCLEOSIS KIT Unipath , Ltd., GB | KTN |
| Aug 4, 1988 | K883004 | MONO-PLUS(TM) Wampole Laboratories | KTN |
| Apr 7, 1988 | K881247 | MONO-PHILE Bio Diagnostic Systems, Inc. | KTN |
| Feb 17, 1988 | K880399 | V-TREND IM DRY-SPOT TEST Texas Immunology, Inc. | KTN |
| Feb 10, 1988 | K880148 | INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST Ampcor, Inc. | KTN |
| Dec 14, 1987 | K874678 | I.M.N. LATEX Biokit USA, Inc. | KTN |
| Dec 14, 1987 | K873297 | DIFFERENTIAL I.M. SCREENING TEST Sclavo, Inc. | KTN |
| Jun 29, 1987 | K872032 | VENTRESCREEN (TM) MONO Ventrex Laboratories, Inc. | KTN |
| Dec 3, 1986 | K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO Gamma Biologicals, Inc. | KTN |
| Jul 3, 1986 | K862008 | MONO-LATEX (TM) SLIDE TEST Armkel, LLC | KTN |
| May 13, 1986 | K861452 | MONOSTAR SYSTEM: IM LATEX TEST U.S. Health Resources Corp. | KTN |
| Apr 18, 1986 | K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS Gamma Biologicals, Inc. | KTN |
| Oct 16, 1985 | K853144 | CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 Preco, Inc. | KTN |
| Sep 3, 1985 | K853105 | IMMUNO-IM Immunostics Co., Inc. | KTN |
| Aug 22, 1985 | K853388 | MONOSTICON UNI-DOT Organon, Inc. | KTN |
| Nov 19, 1984 | K844289 | SERIES I/S INFECTIONS American Dade | KTN |
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