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510(k) K090734

EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES by Medica Corp. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2009
Date Received
March 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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