LIZ — Assay, T Lymphocyte Surface Marker Class II
FDA product code LIZ covers "Assay, T Lymphocyte Surface Marker", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LIZ
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914847 | gen trak | CD8 MONOCLONAL ANTIBODIES | June 19, 1992 |
| K860830 | technicon instruments | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD | September 8, 1986 |
| K843062 | bd becton dickinson vacutainer systems preanalytic | TBM-REAGENT FOR T,B CELL & MONOCYTES | April 3, 1985 |
| K842218 | bd becton dickinson vacutainer systems preanalytic | ANTI-LEU-4 FITC LYSIN C BUFFER | December 27, 1984 |
| K833929 | control diagnostics | WHITE BLOOD CELLS HUMAN TAND B | February 3, 1984 |
| K831053 | bio-rad | QUANTIGEN T & B CELL ASSAY | August 8, 1983 |
| K820643 | ortho diagnostic systems | ORTHO SPECTRUM III & ORTHO-MUNE OK | July 14, 1982 |