510(k) K860830
K860830 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD". The FDA issued a decision of SN on September 8, 1986. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 8, 1986
- Date Received
- March 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, T Lymphocyte Surface Marker
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- IM
- Submission Type