Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTN — Predicate Candidate Screening
59 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
179 days90th percentile
59clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mon | SEKISUI Diagnostics, LLC | 2018-06-22 | 21 | 0 |
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASM | ACON Laboratories, Inc. | 2005-02-28 | 189 | 1 |
| K030215 | BIORAPID MONONUCLEOSIS | Instrumentation Laboratory CO | 2003-02-24 | 34 | 0 |
| K012901 | COLOR-MONOGEN | Instrumentation Laboratory CO | 2001-09-27 | 29 | 0 |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | Oxoid , Ltd. | 1999-01-28 | 184 | 0 |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | 1998-12-10 | 190 | 0 |
| K972457 | MONOCOL/LEX-IM TEST | Immunostics Inc., | 1997-12-01 | 153 | 0 |
| K972231 | OSOM MONO TEST 143 | Wyntek Diagnostics, Inc. | 1997-08-26 | 71 | 0 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | 1997-02-25 | 179 | 0 |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN M | Princeton BioMeditech Corp. | 1997-02-04 | 327 | 0 |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 0 |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | 1993-12-27 | 314 | 0 |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | 1993-09-08 | 97 | 0 |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | 1993-08-09 | 75 | 0 |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Princeton Biomedix | 1993-02-23 | 132 | 0 |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | 1992-11-02 | 83 | 0 |
| K923767 | PULSE IM RED CELL TEST | Pulse Scientific, Inc. | 1992-10-16 | 80 | 0 |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | 122 | 0 |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Ampcor, Inc. | 1992-07-14 | 60 | 0 |
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Ampcor, Inc. | 1992-07-14 | 60 | 0 |
| K920221 | HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY | Akers Research Corp. | 1992-03-13 | 57 | 0 |
| K902510 | CARDS O.S. MONO | Pacific Biotech, Inc. | 1990-07-16 | 41 | 0 |
| K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX | Trinity Laboratories, Inc. | 1990-06-28 | 22 | 0 |
| K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET | Armkel, LLC | 1990-02-26 | 18 | 0 |
| K896926 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS | Quidel Corp. | 1990-01-26 | 46 | 0 |
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Leeco Diagnostics, Inc. | 1989-10-31 | 35 | 0 |
| K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST | Gull Laboratories, Inc. | 1989-10-31 | 26 | 0 |
| K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST | General Biometrics, Inc. | 1989-09-13 | 37 | 0 |
| K894793 | MONODEX | Cenogenics Corp. | 1989-08-21 | 24 | 0 |
| K893737 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST | Quidel Corp. | 1989-06-16 | 30 | 0 |
| K890991 | MONO-CUBE(TM) | Difco Laboratories, Inc. | 1989-03-16 | 17 | 0 |
| K890041 | V-TREND TARGET IM TEST | Texas Immunology, Inc. | 1989-01-23 | 18 | 0 |
| K883709 | MODIFICATION OF MONO-PLUS(TM) | Armkel, LLC | 1988-12-20 | 112 | 0 |
| K884007 | CARDS(TM) MONO | Pacific Biotech, Inc. | 1988-11-18 | 58 | 0 |
| K883540 | OXOID INFECTIOUS MONONUCLEOSIS KIT | Unipath , Ltd. | 1988-10-19 | 62 | 1 |
| K883004 | MONO-PLUS(TM) | Wampole Laboratories | 1988-08-04 | 17 | 0 |
| K881247 | MONO-PHILE | Bio Diagnostic Systems, Inc. | 1988-04-07 | 15 | 0 |
| K880399 | V-TREND IM DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-17 | 19 | 0 |
| K880148 | INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST | Ampcor, Inc. | 1988-02-10 | 28 | 0 |
| K874678 | I.M.N. LATEX | Biokit USA, Inc. | 1987-12-14 | 31 | 0 |
| K873297 | DIFFERENTIAL I.M. SCREENING TEST | Sclavo, Inc. | 1987-12-14 | 118 | 0 |
| K872032 | VENTRESCREEN (TM) MONO | Ventrex Laboratories, Inc. | 1987-06-29 | 33 | 0 |
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Gamma Biologicals, Inc. | 1986-12-03 | 37 | 0 |
| K862008 | MONO-LATEX (TM) SLIDE TEST | Armkel, LLC | 1986-07-03 | 37 | 0 |
| K861452 | MONOSTAR SYSTEM: IM LATEX TEST | U.S. Health Resources Corp. | 1986-05-13 | 25 | 0 |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Gamma Biologicals, Inc. | 1986-04-18 | 31 | 0 |
| K853144 | CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 | Preco, Inc. | 1985-10-16 | 79 | 0 |
| K853105 | IMMUNO-IM | Immunostics Co., Inc. | 1985-09-03 | 42 | 0 |
| K853388 | MONOSTICON UNI-DOT | Organon, Inc. | 1985-08-22 | 9 | 0 |
| K844289 | SERIES I/S INFECTIONS | American Dade | 1984-11-19 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda