510(k) K802376

KODAK EKTA-CHEM CLINICAL CHEM. SLIDES by Eastman Kodak Company — Product Code CHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric Method, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type