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510(k) K110675

EASYRA UREA NITROGEN AND CREATININE REAGENTS by Medica Corp. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2011
Date Received
March 10, 2011
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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