510(k) K980757

ILAB 600 CLINICAL CHEMISTRY SYSTEM by Instrumentation Laboratory CO — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
February 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type