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510(k) K993178

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 by Diagnostic Chemicals , Ltd. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
September 23, 1999
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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