510(k) K912217

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES by Eastman Kodak Company — Product Code DIH

K912217 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES". The FDA issued a decision of Substantially Equivalent on July 1, 1991. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1991
Date Received
May 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type