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

Name: FDA 510(k) clearance K140827
Creator: U.S. Food and Drug Administration
Published: 2015-09-30

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.. Device class: 2.

Clearance details

Applicant: Sd Biosensor, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2014-04-01
Decision date: 2015-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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