510(k) K930484

DELFIA(R) HGH KIT by Wallac OY — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
January 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Growth Hormone
Device Class
Class I
Regulation Number
862.1370
Review Panel
CH
Submission Type