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510(k) K800071

BUN REAGENT KIT by Fisher Scientific Co., LLC — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
January 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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