510(k) K841575

SENTECH'S ULAB 1000 CLINICAL CHEM. by Sen Tech Medical Corp. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
April 17, 1984
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