510(k) K845027

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

K845027 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 January 18, 1985. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1985
Date Received
December 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Device Class
Class I
Regulation Number
862.1465
Review Panel
CH
Submission Type