510(k) K881345

IMX FERRITIN by Abbott Laboratories — Product Code DGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1988
Date Received
March 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type