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510(k) K101088

EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT by Medica Corp. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2011
Date Received
April 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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