LIZ
7 FDA 510(k) clearances · Product code
187 daysmedian time to decision
243 days90th percentile
7clearances measured
FDA profile
- Official device name
- Assay, T Lymphocyte Surface Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CD8 MONOCLONAL ANTIBODIES (K914847) | Gen Trak, Inc. | 1992-06-19 |
| TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD (K860830) | Technicon Instruments Corp. | 1986-09-08 |
| TBM-REAGENT FOR T,B CELL & MONOCYTES (K843062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-04-03 |
| ANTI-LEU-4 FITC LYSIN C BUFFER (K842218) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-27 |
| WHITE BLOOD CELLS HUMAN TAND B (K833929) | Control Diagnostics | 1984-02-03 |
| QUANTIGEN T & B CELL ASSAY (K831053) | Bio-Rad | 1983-08-08 |
| ORTHO SPECTRUM III & ORTHO-MUNE OK (K820643) | Ortho Diagnostic Systems, Inc. | 1982-07-14 |
Track LIZ automatically
Every clearance here is in the API, with alerts when new ones post.