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510(k) K123586

EASYRA CREATININE REAGENT by Medica Corporation — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2013
Date Received
November 21, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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