KTNClass II
System, Test, Infectious Mononucleosis
21 CFR 866.5640 / Immunology
KTN is the FDA product code for System, Test, Infectious Mononucleosis, a class II device type, regulated under 21 CFR 866.5640. As of , FDA records hold 59 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- KTN
- Device name
- System, Test, Infectious Mononucleosis
- Regulation
- 21 CFR 866.5640
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 59
- Ingested recalls
- 9
Clearances, product code KTN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 7 |
| 1989 | 7 |
| 1990 | 4 |
| 1992 | 6 |
| 1993 | 4 |
| 1996 | 1 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code KTN| Applicant | Clearances |
|---|---|
| Ampcor, Inc. | 3 |
| Armkel, LLC | 3 |
| J.S. Medical Assoc. | 3 |
| Texas Immunology, Inc. | 3 |
| Gamma Biologicals, Inc. | 2 |
| Sekisui Diagnostics, LLC | 2 |
| Immunostics, Inc. | 2 |
| Instrumentation Laboratory Co. | 2 |
| Organon LLC | 2 |
| Pacific Biotech, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.