SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set— 510(k) K140827

Substantially Equivalent

Sd Biosensor, Inc.

FDA 510(k) clearance K140827 for SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set, Substantially Equivalent on 2015-09-30. Applicant: Sd Biosensor, Inc..

Clearance details

Applicant: Sd Biosensor, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2014-04-01
Decision date: 2015-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

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