510(k) K842218
- Device
- ANTI-LEU-4 FITC LYSIN C BUFFER
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K842218
- Product code
- LIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-27
- Date received
- 1984-06-04
- Regulation
- 864.5220
- Classification name
- Assay, T Lymphocyte Surface Marker
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL J ARNSBERGE
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 3027394506
- 3008352382
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914847 | CD8 MONOCLONAL ANTIBODIES | Gen Trak, Inc. | 1992-06-19 |
| K860830 | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD | Technicon Instruments Corp. | 1986-09-08 |
| K843062 | TBM-REAGENT FOR T,B CELL & MONOCYTES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-04-03 |
| K833929 | WHITE BLOOD CELLS HUMAN TAND B | Control Diagnostics | 1984-02-03 |
| K831053 | QUANTIGEN T & B CELL ASSAY | Bio-Rad | 1983-08-08 |
| K820643 | ORTHO SPECTRUM III & ORTHO-MUNE OK | Ortho Diagnostic Systems, Inc. | 1982-07-14 |
Legacy Summary#
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FDA Review#
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