510(k) K791128

PTH RIA 200 by Institut National Des Radioelements — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1979
Date Received
June 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type