510(k) K982041

UIBC by Abbott Laboratories — Product Code JMO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1998
Date Received
June 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type