SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
FDA 510(k) clearance K140827 · decided 2015-09-30
Clearance details
- K-number
- K140827
- Device name
- SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- Applicant
- Sd Biosensor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-01
- Decision date
- 2015-09-30
- Days to decision
- 547 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Suwon-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.