510(k) K926345

TRIODOTHYRONINE (TC) COATED TUBE RIA by Monobind — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1993
Date Received
December 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type