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510(k) K981123

UREA by Trace Scientific , Ltd. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1998
Date Received
March 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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