510(k) K140827
K140827 is an FDA 510(k) premarket notification submitted by Sd Biosensor, Inc. for the device "SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set". The FDA issued a decision of Substantially Equivalent on September 30, 2015. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sd Biosensor, Inc. has at least 5 other 510(k) clearances on record.
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