510(k) K833929
K833929 is an FDA 510(k) premarket notification submitted by Control Diagnostics for the device "WHITE BLOOD CELLS HUMAN TAND B". The FDA issued a decision of Substantially Equivalent on February 3, 1984. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Control Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1984
- Date Received
- October 18, 1983
- 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