KTN — System, Test, Infectious Mononucleosis Class II
FDA Device Classification
Classification Details
- Product Code
- KTN
- Device Class
- Class II
- Regulation Number
- 866.5640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K181436 | sekisui diagnostics | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M | June 22, 2018 |
| K042272 | acon laboratories | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | February 28, 2005 |
| K030215 | instrumentation laboratory | BIORAPID MONONUCLEOSIS | February 24, 2003 |
| K012901 | instrumentation laboratory | COLOR-MONOGEN | September 27, 2001 |
| K982634 | oxoid | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | January 28, 1999 |
| K981946 | unipath | CLEARVIEW IM | December 10, 1998 |
| K972457 | immunostics inc | MONOCOL/LEX-IM TEST | December 1, 1997 |
| K972231 | wyntek diagnostics | OSOM MONO TEST 143 | August 26, 1997 |
| K963425 | genzyme diagnostics | GENZYME DIAGNOSTICS CONTRAST MONO | February 25, 1997 |
| K961024 | princeton biomeditech | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | February 4, 1997 |
| K961550 | consolidated technologies | QUALITROL MONO CONTROL SERUM SET | September 24, 1996 |
| K930778 | meridian diagnostics | IMMUNOCARD MONO | December 27, 1993 |
| K932688 | j.s. medical assoc | EYE SPOT IM TEST | September 8, 1993 |
| K932551 | j.s. medical assoc | ACCUTEX IM LATEX TEST | August 9, 1993 |
| K925183 | princeton biomedix | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | February 23, 1993 |
| K924037 | j.s. medical assoc | ACCUTEX IM RBC TEST | November 2, 1992 |
| K923767 | pulse scientific | PULSE IM RED CELL TEST | October 16, 1992 |
| K922726 | simplicity diagnostics | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | October 5, 1992 |
| K922297 | ampcor | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | July 14, 1992 |
| K922296 | ampcor | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | July 14, 1992 |