KTN — System, Test, Infectious Mononucleosis Class II
FDA product code KTN covers "System, Test, Infectious Mononucleosis", a Class II medical device regulated under 21 CFR 866.5640. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |