510(k) K802376

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

K802376 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTA-CHEM CLINICAL CHEM. SLIDES". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code CHS (Coulometric Method, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

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