510(k) K913196

KODAK EKTACHEM DT SLIDES (LIPASE) by Eastman Kodak Company — Product Code CHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
July 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Method, Catecholamines
Device Class
Class I
Regulation Number
862.1165
Review Panel
CH
Submission Type