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510(k) K812027

KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) by Eastman Kodak Company — Product Code CIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Starch-Dye Bound Polymer, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

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Other clearances for product code CIW

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