510(k) K831188

CONNECTOR TUBE by Medrad, Inc. — Product Code DOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type