510(k) K853068

ILEX PROMPT CLINICAL CHEMISTRY ANALYER by Ilex Corp. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1985
Date Received
July 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type