510(k) K142664
K142664 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "URight Hemoglobin A1c system, FORA A1c System". The FDA issued a decision of Substantially Equivalent on January 29, 2016. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2016
- Date Received
- September 18, 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