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510(k) K040973

BUN REAGENT by Genchem, Inc. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2004
Date Received
April 14, 2004
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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