Technicon H.1 System, T Lymphocytes Method
FDA 510(k) K860830 · Technicon Instruments Corp.
510(k) numberK860830
Submission
- Device name
- Technicon H.1 System, T Lymphocytes Method
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- March 5, 1986
- Decision date
- September 8, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
| 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 |
| K831053 | Quantigen T & B Cell AssayLIZ · Traditional | Bio-Rad | 08/08/1983SE |
| K820643 | Ortho Spectrum III & Ortho-Mune OkLIZ · Traditional | Ortho Diagnostic Systems, Inc. | 07/14/1982SE |
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| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
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Questions and answers
When was Technicon H.1 System, T Lymphocytes Method cleared by the FDA?
Technicon H.1 System, T Lymphocytes Method (K860830) received a 510(k) decision of Substantially Equivalent for Some Indications on September 8, 1986, 187 days after the submission was received.
What is the product code of K860830?
The FDA product code is LIZ – Assay, T Lymphocyte Surface Marker, a Class II (moderate risk) device regulated under 21 CFR 864.5220.