Quantigen T & B Cell Assay
FDA 510(k) K831053 · Bio-Rad
510(k) numberK831053
Submission
- Device name
- Quantigen T & B Cell Assay
- Applicant
- Bio-Rad
Mchenry, IL, US - Received
- April 1, 1983
- Decision date
- August 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIZ – Assay, T Lymphocyte Surface Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Other 510(k)s with product code LIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914847 | CD8 Monoclonal AntibodiesLIZ · Traditional | Gen Trak, Inc. | 06/19/1992SE |
| K860830 | Technicon H.1 System, T Lymphocytes MethodLIZ · Traditional | Technicon Instruments Corp. | 09/08/1986SN |
| K843062 | Tbm-Reagent for T,B Cell & MonocytesLIZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/03/1985SE |
| K842218 | ANTI-LEU-4 Fitc Lysin C BufferLIZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/27/1984SE |
| K833929 | White Blood Cells Human Tand BLIZ · Traditional | Control Diagnostics | 02/03/1984SE |
| K820643 | Ortho Spectrum III & Ortho-Mune OkLIZ · Traditional | Ortho Diagnostic Systems, Inc. | 07/14/1982SE |
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Questions and answers
When was Quantigen T & B Cell Assay cleared by the FDA?
Quantigen T & B Cell Assay (K831053) received a 510(k) decision of Substantially Equivalent on August 8, 1983, 129 days after the submission was received.
What is the product code of K831053?
The FDA product code is LIZ – Assay, T Lymphocyte Surface Marker, a Class II (moderate risk) device regulated under 21 CFR 864.5220.