510(k) K890689

ADX TM OPIATES by Abbott Laboratories — Product Code DGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1989
Date Received
February 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colostrum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5230
Review Panel
IM
Submission Type