Home / 510(k) Clearances / K854139

510(k) K854139

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB by Eastman Kodak Company — Product Code KHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
October 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Blood Hemoglobin Determination
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

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