510(k) K833929

WHITE BLOOD CELLS HUMAN TAND B by Control Diagnostics — Product Code LIZ

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