510(k) K161533
K161533 is an FDA 510(k) premarket notification submitted by Biohermes Co., Ltd. for the device "A1C EZ Glycohemoglobin Analysis System". The FDA issued a decision of Substantially Equivalent on June 16, 2017. 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
- June 16, 2017
- Date Received
- June 2, 2016
- 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