SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
FDA 510(k) K140827 · Sd Biosensor, Inc.
510(k) numberK140827
Submission
- Device name
- SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- Applicant
- Sd Biosensor, Inc.
Suwon-Si, KR - Received
- April 1, 2014
- Decision date
- September 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
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| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…NBW · Traditional | 11/24/2015SE |
| K132929 | SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…NBW · Traditional | 08/05/2015SE |
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Questions and answers
When was SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set cleared by the FDA?
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (K140827) received a 510(k) decision of Substantially Equivalent on September 30, 2015, 547 days after the submission was received.
What is the product code of K140827?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.