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510(k) K941142

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN by Eastman Kodak Company — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1994
Date Received
March 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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