510(k) K840151

EKTACHEM CLINICAL CHEM. SLIDES by Eastman Kodak Company — Product Code CED

K840151 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "EKTACHEM CLINICAL CHEM. SLIDES". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
January 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Device Class
Class I
Regulation Number
862.1520
Review Panel
CH
Submission Type