510(k) K884649

TOTAL IRON BINDING CAPACITY TEST by Sclavo, Inc. — Product Code JQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1988
Date Received
November 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type