510(k) K861387

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) by Eastman Kodak Company — Product Code JHS

K861387 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)". The FDA issued a decision of Substantially Equivalent on June 27, 1986. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1986
Date Received
April 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type