510(k) K934273

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) by Eastman Kodak Company — Product Code DMT

K934273 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)". The FDA issued a decision of Substantially Equivalent on March 21, 1994. The device falls under product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet), a Class II device regulated under 21 CFR 862.3040. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1994
Date Received
August 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type