510(k) K173127
K173127 is an FDA 510(k) premarket notification submitted by Skyla Corporation H.S.P.B for the device "skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)". The FDA issued a decision of Substantially Equivalent on September 25, 2018. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2018
- Date Received
- September 29, 2017
- 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