WHITE BLOOD CELLS HUMAN TAND B
FDA 510(k) clearance K833929 · decided 1984-02-03
Clearance details
- K-number
- K833929
- Device name
- WHITE BLOOD CELLS HUMAN TAND B
- Applicant
- Control Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1983-10-18
- Decision date
- 1984-02-03
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- LIZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.