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510(k) K120497

EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL by Medica Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2012
Date Received
February 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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