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510(k) K140827

SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set by Sd Biosensor, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2015
Date Received
April 1, 2014
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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