FDA Product Code
FDA Product Code KTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5640
510(k) Clearances — 59 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | SEKISUI Diagnostics, LLC | 2018-06-22 | Special | PDF ↗ |
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | ACON Laboratories, Inc. | 2005-02-28 | Traditional | PDF ↗ |
| K030215 | BIORAPID MONONUCLEOSIS | Instrumentation Laboratory CO | 2003-02-24 | Traditional | PDF ↗ |
| K012901 | COLOR-MONOGEN | Instrumentation Laboratory CO | 2001-09-27 | Traditional | PDF ↗ |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | Oxoid , Ltd. | 1999-01-28 | Traditional | PDF ↗ |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | 1998-12-10 | Traditional | PDF ↗ |
| K972457 | MONOCOL/LEX-IM TEST | Immunostics Inc., | 1997-12-01 | Traditional | PDF ↗ |
| K972231 | OSOM MONO TEST 143 | Wyntek Diagnostics, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | 1997-02-25 | Traditional | PDF ↗ |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | Princeton BioMeditech Corp. | 1997-02-04 | Traditional | PDF ↗ |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | 1993-12-27 | Traditional | PDF ↗ |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | 1993-09-08 | Traditional | PDF ↗ |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | 1993-08-09 | Traditional | PDF ↗ |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Princeton Biomedix | 1993-02-23 | Traditional | PDF ↗ |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | 1992-11-02 | Traditional | PDF ↗ |
| K923767 | PULSE IM RED CELL TEST | Pulse Scientific, Inc. | 1992-10-16 | Traditional | PDF ↗ |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Ampcor, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Ampcor, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K920221 | HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY | Akers Research Corp. | 1992-03-13 | Traditional | PDF ↗ |
| K902510 | CARDS O.S. MONO | Pacific Biotech, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX | Trinity Laboratories, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET | Armkel, LLC | 1990-02-26 | Traditional | PDF ↗ |
| K896926 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS | Quidel Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST | Gull Laboratories, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Leeco Diagnostics, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST | General Biometrics, Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K894793 | MONODEX | Cenogenics Corp. | 1989-08-21 | Traditional | PDF ↗ |
| K893737 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST | Quidel Corp. | 1989-06-16 | Traditional | PDF ↗ |
| K890991 | MONO-CUBE(TM) | Difco Laboratories, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K890041 | V-TREND TARGET IM TEST | Texas Immunology, Inc. | 1989-01-23 | Traditional | PDF ↗ |
| K883709 | MODIFICATION OF MONO-PLUS(TM) | Armkel, LLC | 1988-12-20 | Traditional | PDF ↗ |
| K884007 | CARDS(TM) MONO | Pacific Biotech, Inc. | 1988-11-18 | Traditional | PDF ↗ |
| K883540 | OXOID INFECTIOUS MONONUCLEOSIS KIT | Unipath , Ltd. | 1988-10-19 | Traditional | PDF ↗ |
| K883004 | MONO-PLUS(TM) | Wampole Laboratories | 1988-08-04 | Traditional | PDF ↗ |
| K881247 | MONO-PHILE | Bio Diagnostic Systems, Inc. | 1988-04-07 | Traditional | PDF ↗ |
| K880399 | V-TREND IM DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K880148 | INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST | Ampcor, Inc. | 1988-02-10 | Traditional | PDF ↗ |
| K874678 | I.M.N. LATEX | Biokit USA, Inc. | 1987-12-14 | Traditional | PDF ↗ |
| K873297 | DIFFERENTIAL I.M. SCREENING TEST | Sclavo, Inc. | 1987-12-14 | Traditional | PDF ↗ |
| K872032 | VENTRESCREEN (TM) MONO | Ventrex Laboratories, Inc. | 1987-06-29 | Traditional | PDF ↗ |
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Gamma Biologicals, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K862008 | MONO-LATEX (TM) SLIDE TEST | Armkel, LLC | 1986-07-03 | Traditional | PDF ↗ |
| K861452 | MONOSTAR SYSTEM: IM LATEX TEST | U.S. Health Resources Corp. | 1986-05-13 | Traditional | PDF ↗ |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Gamma Biologicals, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K853144 | CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 | Preco, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K853105 | IMMUNO-IM | Immunostics Co., Inc. | 1985-09-03 | Traditional | PDF ↗ |
| K853388 | MONOSTICON UNI-DOT | Organon, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K844289 | SERIES I/S INFECTIONS | American Dade | 1984-11-19 | Traditional | PDF ↗ |
| K841863 | MONO-TEC | Medilab Corp. | 1984-06-13 | Traditional | PDF ↗ |
| K840822 | LEAP MONO TEST KIT | Cooper Biomedical, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K834345 | IM-CHECK | Diagnostic Technology, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K830531 | MONO SCREENING TEST | Tago, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K821386 | SERO/TEX MONO TEST | Texas Immunology, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K812540 | CORDIA IM | Cordis Corp. | 1981-09-24 | Traditional | PDF ↗ |
| K791455 | AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS | Volu Sol Medical Industries | 1979-12-31 | Traditional | PDF ↗ |
| K771397 | MONOSTICON TEST | Organon, Inc. | 1977-08-22 | Traditional | PDF ↗ |
| K760040 | TEST, MONO., CARD (MACRO-VUE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 | Traditional | PDF ↗ |
Product code KTN · Class II · Immunology. Data: openFDA.