Panels › Hematology › Product code LIZ · Class 2
Assay, T Lymphocyte Surface Marker
Regulation 864.5220
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LIZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Becton, Dickinson and Company, BD Biosciences | 0 | 1 |
| Bio-Rad | 1 | 0 |
| Control Diagnostics | 1 | 0 |
| Gen Trak, Inc. | 1 | 0 |
| Ortho Diagnostic Systems, Inc. | 1 | 0 |
| Technicon Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 1992 | K914847 | CD8 MONOCLONAL ANTIBODIES Gen Trak, Inc. | LIZ |
| Sep 8, 1986 | K860830 | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD Technicon Instruments Corp. | LIZ |
| Apr 3, 1985 | K843062 | TBM-REAGENT FOR T,B CELL & MONOCYTES Bd Becton Dickinson Vacutainer Systems Preanalytic | LIZ |
| Dec 27, 1984 | K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER Bd Becton Dickinson Vacutainer Systems Preanalytic | LIZ |
| Feb 3, 1984 | K833929 | WHITE BLOOD CELLS HUMAN TAND B Control Diagnostics | LIZ |
| Aug 8, 1983 | K831053 | QUANTIGEN T & B CELL ASSAY Bio-Rad | LIZ |
| Jul 14, 1982 | K820643 | ORTHO SPECTRUM III & ORTHO-MUNE OK Ortho Diagnostic Systems, Inc. | LIZ |
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