510(k) K822684

ENDAB THYROID UPTAKE by Immunotech Corp. — Product Code CEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1982
Date Received
September 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
Review Panel
CH
Submission Type